Model SN60D3, Serial numbers: 968290.039; 934317.012; 934317.013; and 948332.080.

Ophthalmic Devices

3

No

Nationwide.

AcrySof¿ ReSTOR¿ Intraocular Lens

Model MN60D3, Serial numbers: 940376.028; 945173.084; 945533.043; 945174.053; 944089.027; 942202.069; 940407.058; 940407.059; 942210.016; and 945537.073

Ophthalmic Devices

3

No

Nationwide.

AcrySof¿ ReSTOR¿ Intraocular Lens

Lot Codes: B00DJPQ, -7.00D B00DMHZ, -6.00D B00DMJP, +4.00D

Ophthalmic Devices

2

No

Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico; and countries of: Austria, Belgium, Canada, Costa Rica, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea, Japan, Luxembourg, Netherlands, Portugal, Norway, South Africa, Slovenia, Spain, Sweden, and United Kingdom.

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. || The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less.

Lot B006X641

Ophthalmic Devices

3

No

Worldwide Distribution: USA including all states, District of Columbia and Puerto Rico, and the countries of Canada, Bahamas, Honduras, and United Arab Emirates.

Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) || Mislabeled Outer (secondary) Label: Lot B006X641 || D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose.

Units manufactured between August 2007 and 20 February 2011.

Ophthalmic Devices

2

No

worldwide distribution

Alcon 3000LE ophthalmic laser

1) 23G TotalPLUS Pak: Accurus Standalone - 8065750828, 2) 23G Combined Pack 0.9mm: Accurus Standalone - 8065750814, 3) 23G Combined Pack 1.1mm: Accurus Standalone - 8065750816, 4)23G TotalPLUS Pak: Constellation Standalone - 8065751058, 5) 23G Combined Pack 0.9mm: Constellation Standalone -8065751077, 6) 23G Combined Pack 1.1mm: Constellation Standalone - 8065751065. 7) 23G Small Parts Kit - 8065750842. Complete list of lot numbers will be provided with recall recommendation.

Ophthalmic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.

This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. || Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.

2060953H

Ophthalmic Devices

2

No

Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine

Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak || Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

Accurus 23 GA Standalone Vitreous Probe: Lot Number: 14010428X, Expiration Date: 1/14/2017; Lot Number: 14012987X, Expiration Date: 2/17/2017; Lot Number: 14014736X, Expiration Date: 3/11/2017; Lot Number: 14016577X, Expiration Date: 3/26/2017; Lot Number: 14017912X, Expiration Date: 4/27/2017; Lot Number: 14020280X, Expiration Date: 5/21/2017; Lot Number: 14022920X, Expiration Date: 6/19/2017; Lot Number: 14024168X, Expiration Date: 6/22/2017; Lot Number: 14026031X, Expiration Date: 7/27/2017; Lot Number: 14028553X, Expiration Date: 8/12/2017; Lot Number: 14029477X, Expiration Date: 8/26/2017; Lot Number: 14033830X, Expiration Date: 10/14/2017; Lot Number: 14036315X, Expiration Date: 11/17/2017;  Accurus 25+ 2500 CPM Stand-Alone Vitreous Probe: Lot Number: 14010429X, Expiration Date: 1/14/2014; Lot Number: 14012985X, Expiration Date: 2/17/2017; Lot Number: 14014737X Expiration Date: 3/11/2017; Lot Number: 14016477X Expiration Date: 3/26/2017; Lot Number: 14018320X Expiration Date: 4/27/2017; Lot Number: 14020282X Expiration Date: 5/21/2017; Lot Number: 14022922X Expiration Date: 6/19/2017; Lot Number: 14026032X Expiration Date: 7/27/2017; Lot Number: 14028554X Expiration Date: 8/12/2017; Lot Number: 14033831X Expiration Date: 10/15/2017; Lot Number: 14036315X Expiration Date: 11/16/2017;   Anterior Accurus Probe with Infusion Needle: Lot Number: 14010430X Expiration Date: 1/14/2017; Lot Number: 14012984X Expiration Date: 2/17/2017; Lot Number: 14014739X Expiration Date: 3/11/2017; Lot Number: 14017451X Expiration Date: 4/15/2017; Lot Number: 14020283X Expiration Date: 5/21/2017; Lot Number: 14022923X Expiration Date: 6/19/2017; Lot Number: 14024219X Expiration Date: 6/22/2017; Lot Number: 14026034X Expiration Date: 7/27/2017; Lot Number: 14028555X Expiration Date: 8/12/2017; Lot Number: 14031264X Expiration Date: 9/22/2017; Lot Number: 14033832X Expiration Date: 10/15/2017;  Accurus 2500 Stand-Alone Vitreous Probe: Lot Number: 14014738X Expiration Date: 3/11/2017; Lot Number: 14017452X Expiration Date: 4/15/2017; Lot Number: 14020246X Expiration Date: 5/21/2017; Lot Number: 14022921X Expiration Date: 6/19/2017; Lot Number: 14026030X Expiration Date: 7/27/2017; Lot Number: 14028440X Expiration Date: 8/6/2017; Lot Number: 14031263X Expiration Date: 9/22/2017; Lot Number: 14033833X Expiration Date: 10/15/2017; Lot Number: 14036297X Expiration Date: 11/16/2017

Ophthalmic Devices

2

No

Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, India, International APL, Italy, Japan, Kenya, Korea, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Poland, Russia, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. || Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.

Lot Numbers: F58834, F60464, F60465 and F60466.

Ophthalmic Devices

1

No

Nationwide Distribution including states of AL and CA.

Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories, Inc., Fort Worth, TX 76134.

Serial Numbers: LWN1002Z LWN1003Z LWN1010Z LWN1011Z LWN1013Z LWN1023Z LWN1025Z LWN1035Z LWN1040Z LWN1440Z LWN1513Z LWN1522Z LWN1626Z LWN1629Z LWN1647Z LWN1748Z LWN1796Z LWN1805Z LWN1817Z LWN1820Z LWN1821Z LWN1822Z LWN1823Z LWN1843Z LWN1846Z LWN1944Z LWN1945Z LWN1946Z LWN1947Z LWN1949Z LWN1950Z LWN1952Z LWN1953Z LWN1954Z LWN1955Z LWN1956Z LWN1957Z LWN1958Z LWN1959Z LWN1961Z LWN2187Z LWN2188Z LWN2189Z LWN2190Z LWN2191Z LWN2192Z LWN2193Z LWN2194Z LWN2197Z LWN2198Z LWN2199Z LWN2200Z LWN2262Z LWN2263Z LWN2264Z LWN2265Z LWN2267Z LWN2268Z LWN2269Z LWN2270Z LWN2271Z LWN2272Z LWN2273Z LWN2276Z LWN2277Z LWN2278Z LWN2279Z LWN2280Z LWN2342Z LWN2343Z LWN2344Z LWN2345Z LWN2346Z LWN2347Z LWN2348Z LWN2349Z LWN2350Z LWN2351Z LWN2352Z LWN2353Z LWN2355Z LWN2356Z LWN2357Z LWN2403S LWN2404S LWN2405S LWN2406S LWN2414Z LWN2415Z LWN2416Z LWN2417Z LWN2420Z LWN2421Z LWN2427S LWN2428S LWN2464Z LWN2465Z LWN2466Z LWN2467Z LWN2468Z LWN2469Z LWN2470Z LWN2471Z LWN2472Z LWN2473Z LWN2475Z LWN2476Z LWN2477Z LWN2478Z LWN1609Z LWN1951Z

Ophthalmic Devices

109 U.S. customers and 48 international device locations. There were 12 devices on-hand.

Alcon Ladarwave CustomCornea Wavefront System'' Aberrometer software Version 7.91

Lot F58507

Ophthalmic Devices

1

No

Nationwide- Hospitals in MD and MN.

19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd., Schaffhauxen, Switzerland CH8203.

AZ034720 AZ152310 AZ152320

Ophthalmic Devices

2

No

Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.

Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 || Product Usage: || The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

AZ133020

Ophthalmic Devices

2

No

Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.

Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 || Product Usage: || The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.

AZ150110 AZ150120 AZ103810 AZ053210 AZ150510 AZ117720 AZ134110 AZ151520 AZ071720 AZ130410 AZ130420

Ophthalmic Devices

2

No

Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.

Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 || Product Usage: || The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

AZ150010 AZ150020 AZ126720 AZ153710 AZ153720 AZ136110 AZ146910 AZ146920 AZ143710 AZ143720 AZ146610 AZ146620 AZ156210 AZ156220 AZ151510 AZ155210 AZ138410 AZ138420 AZ154810 AZ154620 AZ162310 AZ162320 AZ159810 AZ159820 AZ145220 AZ151120

Ophthalmic Devices

2

No

Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.

Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 || Product Usage: || The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.

AZ150620 AZ159220 AZ156710 AZ156720

Ophthalmic Devices

2

No

Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.

Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 || Product Usage: || The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.

AZ160210 AZ151320

Ophthalmic Devices

2

No

Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.

Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 || Product Usage: || The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

AZ139610 AZ139620

Ophthalmic Devices

2

No

Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.

Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 || Product Usage: || The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

AZ162110 AZ162120 AZ158510 AZ158520 AZ160420

Ophthalmic Devices

2

No

Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.

Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 || Product Usage: || The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.

All units of these Catalog Numbers. Part Number: 0070-1531, Catalog Numbers:  0070-1664,0070-1649,0070-1654: Version 3.67 0070-1721: Version 3.671  0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 nternational version

Ophthalmic Devices

3

No

Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britian, Greece, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Netherland, New Zealand, Peru, Philippines, Portugal, Russia, Russia Federation, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, ThailandChina, India, South Korea, Singapore, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela, and Vietnam.

AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, || Part Number: 0070-1531, Catalog Numbers: || 0070-1664,0070-1649,0070-1654: Version 3.67 || 0070-1721: Version 3.671 || 0070-1662: Version 3.67, US version; || 0070-1668; IVersion 3.67 International version || Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA || The WaveScan WaveFront System is a class III accessory device used in conjunction with the VISX¿ STAR S4 and STAR S4 IRTM Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan WaveFront System is a diagnostic instrument intended for the automated measurement, analysis, and recording of refractive errors of the eye. The WaveScan System software uses the diagnostic data of the eye's refractive errors and wavefront aberrations to calculate the target treatment shape and then generates the commands for the VISX STAR laser to create the target shape on the cornea.

Lot # Exp. date 3JR190 10/2006 3KR128 11/2006 3LR100 12/2006 3MR002 12/2006 3MR047 12/2006 3MR048 12/2006 3MR081 01/2007 3MR082 01/2007 4AR045 01/2007 4AR050 01/2007 4AR058 01/2007

Ophthalmic Devices

2

No

Distribution was to 67 domestic customers and internationally.

Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40

VISX STAR Excimer Laser Sysem 0030-4864 Chair component of the System 0030-2381 Each chair also has a serial number, which is the same as the serial number assigned to the system it is part of. Serial Numbers:  2129 2146 2181 2197 3028 3030 3031 3036 3480 3624 5346 5635 3751 3863 5345 5088 3113 5065 3938 2158 2177 2204 2205 3254 3387 3397 3754 3937 5030 5122 3023 3194 3435 3456 3732 3830 5027 5283 5313 5334 5382 5456 5566 5606 5643 3037 3122 3130 3233 3246 3874 5006 5021 5032 5125 5224 5415 5671 3574 5306 5695 3816 2200 3029 3284 3293 3528 3536 3697 3712 3731 3802 3840 3927 5012 5014 5034 5064 5079 5151 5153 5154 5175 5231 5267 5287 5307 5317 5410 5559 5573 5656 5720 5779 3884 5649 3314 3974 5495 3241 and 5127

Ophthalmic Devices

3

No

Worldwide Distribution - USA, including the states of: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV and countries of: Argentina Australia Austria Bahrain Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Cyprus Czech Republic Djibouti Dominican Rep. Ecuador Egypt Finland France Germany Great Britain Greece Hong Kong India Indonesia Ireland Israel Italy Japan Jordan Kasachstan Kuwait Lebanon Malaysia Martinique Mexico Mongolia Netherlands New Zealand Norway Oman Pakistan Paraguay Philippines Poland Portugal Russian Fed. Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Taiwan Thailand Trinidad,Tobago Turkey Unit.Arab Emir. Venezuela Vietnam

AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051

Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units)

Ophthalmic Devices

2

No

Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.

AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.

All systems with software version 3.65 and earlier: Part Numbers 0070-0150, 0070-0150R, 0070-1006, 0070-1006R, and 0070-1478.

Ophthalmic Devices

3

No

Class 2 Recall - Worldwide Distribution: USA, Venezuela, Colombia, Italy, Saudi Arabia, Kuwait, Egypt, UAE, Jordan, Lebanon, Australia, Canada, France, Germany, India, Ireland, Japan, Sweden, Vietnam, Czech Republic, Slovak Republic, Bulgaria, Philippines, South Korea, Turkey, UK, Portugal, Spain, Argentina, Israel, Cyprus, India, Mexico, Greece, Singapore, Chile, Poland, Brazil, China, Thailand, Taiwan, Hong Kong and Russia.

Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones.

Serial Numbers:  10560 70250 70594 75133 12280 70252 70608 75137 14480 70259 70620 75172 70026 70260 70647 75183 70029 70261 70653 75192 70032 70267 70654 75198 70049 70268 70664 75233 70050 70271 70679 75241 70053 70274 70681 75248 70064 70278 70685 75263 70068 70279 70689 75267 70070 70328 70696 75276 70079 70334 70699 75278 70080 70354 70706 75280 70082 70362 70716 75297 70089 70366 70732 75301 70094 70376 70746 75305 70096 70386 70755 75354 70098 70391 70765 75401 70099 70406 70769 75412 70102 70421 70779 75445 70107 70425 70784 76014 70113 70427 70803 76062 70114 70429 70834 76080 70120 70451 70851 76105 70122 70453 70862 76117 70125 70456 70879 76118 70127 70475 70882 76190 70133 70495 70889 76195 70140 70496 70890 76216 70146 70497 75023 76217 70148 70501 75031 76223 70158 70504 75037 76233 70166 70506 75040 76259 70185 70512 75058 76273 70188 70537 75065 76274 70189 70539 75102 76356 70208 70548 75103 76384 70232 70549 75121 70241 70587 and 75126

Ophthalmic Devices

3

No

Product was distributed to 152 customers throughout the United States.

AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The device is used in conjunction with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors of the eye.