Lot# 528020R - Serial Numbers: 55839, 60778, 60848, 60957, 61391, 170021, 185765, 185766, 185768, 185769, 185946, 190014, 190015, 190018, 2004053, 2004578, 209584, 209585, 209586, 209587, 209611, 209627, 209628, 209629, 209631, 170022, 170023, 190019, 190021, 190025, 220048, 222535, 53049, 62327, 223207, 240031, 240032, 240039, 240040, 240048

Ophthalmic Devices

2

Yes

USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey

Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer

GS2014 GL2014 GL2015 GS2015

Ophthalmic Devices

2

Yes

Nationwide Distribution

Molteno3 Glaucoma Implants G-Series: || GS-Single Plate 175mm2 (IOP reorder#: M3-175) || GL-Single Plate 230mm2 (IOP reorder#: M3-230)

model number 14150. lot number 7381

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Venus Eye sphere 10 mm (Sterile)

model number 14151. lot number 8284

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Venus Eye Sphere 12 mm (Sterile)

model number 14152. lot number 8447

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Venus Eye Sphere 14 mm (Sterile)

model number 14153. lot number 8159

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Venus Eye Sphere 16 mm (Sterile)

model number 14154. lot number 8447

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Venus Eye Sphere 18 mm (Sterile)

model number 14155. lot number 8404

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Venus Eye Sphere 20 mm (Sterile)

model number 14156. lot number 8447

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Venus Eye Sphere 22 mm (Sterile)

model number 14164. lot number 8264B

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Conformer - Small (Sterile)

model number 14165. lot number 1187

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Conformer - Medium (Sterile)

model number 14166. lot number 1218

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Conformer - Large (Sterile)

model number 14167. lot number 1233

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Conformer - Small with holes (Sterile)

model number 14168. lot number 1234

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Conformer - Medium with holes (Sterile)

model number 14169. lot number 1235

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Conformer - Large with holes (Sterile)

Lot A004A02

Ophthalmic Devices

2

Yes

AZ, IL, NJ and Korea

MEDPOR¿ Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 * Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA

Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939

Ophthalmic Devices

2

Yes

Internationally to Finland & France

Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S

Lot number: M-50021 Product is not serialized.  Note: Lot code assigned by the contract manufacturing firm.

Ophthalmic Devices

2

Yes

Worldwide, including USA, United Arab Emirates, Canada, Mexico, Costa Rica, Taiwan & Romania.

Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045 || The threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support System. The threaded sleeve is an externally threaded cylinder and an internal drilled hole designed to receive a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K Titanium threaded sleeve wrench after a hole has been prepared in the implant by drilling with a series of hypodermic needles of gradually increasing sizes. After the threaded sleeve is placed in the implant, any of the P-K Pegs can be inserted. || The affected model which is the subject of this recall comes with the flat peg.

P/N 6003, Serial numbers: 10671A through 10714A; 10807A through 10813A; 108866A through 10905A

Ophthalmic Devices

2

Yes

Nationwide, Canada, Columbia, Turkey, & The Netherlands

Krupin Eye Valve, P/N 6003

Serial numbers: 10727A, 10733A, 10734A, 10735A, 10736A, 10737A, 10744A, 10745A, 10746A, 10747A, 10748A, 10749A, 10750A, 10751A, 10794A, 107795A, 10796A, 10797A, 10798A, 10799A, 10806A, 11056A through 11101A, and 11443A through 11456A.

Ophthalmic Devices

2

Yes

Nationwide, Canada, Columbia, Turkey, & The Netherlands

Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209V

Serial numbers: 10744A through 10751A, 11042A through 11047A, 11511A, 11512A, 11518A, 11550A, 11551A, 11554A, 11556A, and 11559A

Ophthalmic Devices

2

Yes

Nationwide, Canada, Columbia, Turkey, & The Netherlands

Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V

Serial numbers: 11102A through 11107A

Ophthalmic Devices

2

Yes

Nationwide, Canada, Columbia, Turkey, & The Netherlands

Valve-EV Glaucoma Ultra-Smooth, P/N 6006

Lot/Unit Codes: 32764, 35906, 35907, 35908, 36307, 36308, 36309, 36315, 36316, 36364, 36430, 36431, 36469, 36470, 36471, 36476, 49216, 54304, 54569, 63449, 63450, 63710, 63803.

Ophthalmic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of nationwide and worldwide to: Japan, Greece, Germany, Romania, UAE, Australia, Canada, Philippines, Korea, Taiwan, Chile, Denmark, UK, Italy, Pakistan, Turkey, Philippines, India, South Africa, and Singapore.

Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. || Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital. || Model Number: I0016C, I0018C, I0020C, I0022C, I0024C. || Description of the product: The Coated Bio-Eye consists of a coralline hydroxyapatite sphere encased in a resorbable shell that aids in || implant insertion and provides a means of securing muscles to the implant. || The Coated Bio-Eye Orbital Implant is indicated in orbital implantation following enucleation, or as a secondary orbital implant following extrusion, migration or rotation of primary orbital implants. It is indicated in any situation where materials such as silicone, acrylic, polyethylene or glass orbital implants would be used.

Catalog number: 80062, Lot Codes: F000689 and G004528.

Ophthalmic Devices

2

Yes

US Distribution, the state of Michigan.

MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan, GA 30265. MEDPOR PLUS Orbital Implants are intended to restore the volume of an enucleated or eviscerated eye globe.

Serial No. 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 119071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 1190071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1276941307, 1309961307.

Ophthalmic Devices

3

Yes

Distributed in the states of OK, KS, FL, and AL.

Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. || The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification.