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

Model MA60AC, serial number 989984.028

Ophthalmic Devices

3

No

Nationwide.

AcrySof¿ Intraocular Lens

All lots

Ophthalmic Devices

2

No

Class II Recall - Worldwide Distribution --- USA including states of MO, NC, FL, CA, and TX and countries of Canada, China, Japan, Australia, Hong Kong, India, Singapore, Korea, Taiwan, Thailand, Argentina, Brazil, Mexico, and The Netherlands

Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX. The firm names on the label are Bausch & Lomb Incorporated, Rochester, NY, and Bausch & Lomb Incorporated, Kingston-upon-Thames, UK.

All lots

Ophthalmic Devices

2

No

Class II Recall - Worldwide Distribution --- USA including states of MO, NC, FL, CA, and TX and countries of Canada, China, Japan, Australia, Hong Kong, India, Singapore, Korea, Taiwan, Thailand, Argentina, Brazil, Mexico, and The Netherlands

Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No: CX4925, containing 1/25-ga. cutter along with accessories, RX. The firm names on the label are Bausch & Lomb Incorporated, Rochester, NY, and Bausch & Lomb Incorporated, Kingston-upon-Thames, UK.

Lot #627618H and 636380H.

Ophthalmic Devices

1

No

Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.

Alcon Custom-Pak¿, part #2638-17, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.

Lot #629460H, 631237H, 632356H and 642330H.

Ophthalmic Devices

1

No

Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.

Alcon Custom-Pak¿, part #4917-54, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.

Lot #633317H, 645074H, and 629784H.

Ophthalmic Devices

1

No

Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.

Alcon Custom-Pak¿, part #6515-51, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.

Lot #632178H, 634400H and 642229H.

Ophthalmic Devices

1

No

Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.

Alcon Custom-Pak¿, part #11148-02, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.

Ophthalmic Devices

Model numbers 59051,59081,60081 Model numbers 59051L, 59081L, 60051L, 60081L The OVD containing recalled cannula was manufactured between February 2010 to August 2012 with expiry dates ranging from December 2001 to June 2015

Ophthalmic Devices

OVD, Amvisc and Amvisc Plus devices

Ophthalmic Devices

ophthalmological technology - liquid media for ophthalmological purposes

Ophthalmic Devices

ophthalmological technology

Ophthalmic Devices

ophthalmological technology

Ophthalmic Devices

ophthalmological technology

Ophthalmic Devices

ophthalmological technology

Ophthalmic Devices

Medical Device Safety Alert: Bausch & Lomb Disposable cannulas provided with Amvisc and Amvisc Plus Sodium Hyaluronate

Ophthalmic Devices

Press release: Recall of AMO Contact Lens Solution

Ophthalmic Devices

Medical Device Safety Alert: Alcon CyPass Micro-Stent

Ophthalmic Devices

Press release: Suspend use of Avaira Toric daily contact lenses advisable

Ophthalmic Devices

Press release: Recall of Avaira Toric and BioComfort XO Toric contact lenses

Ophthalmic Devices

Press release: Recall of Avaira and BioComfort XO contact lense

Ophthalmic Devices

CyPass® Micro-Stent, Alcon Laboratories Inc.

Model Octopus 101. SN: 119, 136, 165, 166, 221, 222, 225, 236, 243, 273, 277, 279, 370, 371, 392, 507, 541, 553, 570, 602, 603, 611, 620, 622, 661, 667, 668, 687, 690, 726, 741, 744, 794, 796, 1054, 1214, 1275, 1276, 1277, 1313, 1322, 1326, 1380, 1402, 1404, 1413, 1414, 1436, 1437, 1459, 1460, 1489, 1490, 1491, 1492, 1560, 1561, 1607, 1608, 1625, 1626, 1706, 1710, 1852

Ophthalmic Devices

1

No

Worldwide distribution: USA (nationwide) including states of: AR, CA, CT, FL, GA, IA, IL, LA, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, SD, WA, WI, and WV; and to the countries of Jamaica, Puerto Rico, and Mexico.

Octopus 101 Perimeter; PeriTrend Software Analysis || A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

Serial Numbers: FLM4135, FLM3281, FLM2963, FLM3907, FLM3817

Ophthalmic Devices

2

No

Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany.

1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. || 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. || 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.

All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01

Ophthalmic Devices

2

No

Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Egypt, France, Germany, Great Britain, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Kyrgyzstan, Lebanon, Korea, Malaysia, Mexico, Pakistan, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Turkistan, Venezuela, and Veit Nam.

The Constellation Vision System Pneumatic Handpiece. || Indicated for both anterior and posterior segment opthalmic surgery.