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Folders And Injectors, Intraocular Lens (Iol)
FDA product code MSS · Class 1 · Ophthalmic
54
Registered devices
5,344
Adverse events
5
Recalls
63
510(k) clearances
Devices with this code
bioli™ IOL Delivery System — AST PRODUCTS, INC.EyeGility™ Inserter — Bausch & Lomb IncorporatedI9011S — Lenstec Barbados Incpioli™ IOL Delivery System — AST PRODUCTS, INC.ASICO ROYALE III CLEANING INJECTOR — KATENA PRODUCTS, INC.LC16 — Lenstec Barbados IncMicroStaar — STAAR SURGICAL COMPANYVISCOJECT 2.2 INJECTOR-SET — Medicel AGCARTM — Lenstec Barbados IncBausch + Lomb — Bausch & Lomb Incorporatedpioli™ IOL Delivery System — AST PRODUCTS, INC.VISCOJECT 1.8 Injector set — Medicel AGMicroStaar — STAAR SURGICAL COMPANYASICO ROYALE III INJECTOR — KATENA PRODUCTS, INC.I9012FS — Lenstec Barbados IncSofport Easy-Load Lens Delivery System EZ-24 — Bausch & Lomb Incorporatedlioli™ IOL Delivery System — AST PRODUCTS, INC.Accuject REFRA 2.9 Injector — Medicel AGMicroStaar — STAAR SURGICAL COMPANYVISCOJECT 2.2 INJECTOR-SET — Medicel AGlioli™ IOL Delivery System — AST PRODUCTS, INC.RxSight Injector Cartridge — RXSIGHT, INC.VITAN — JOHNSON & JOHNSON SURGICAL VISION, INC.BLIS-X0 — Bausch & Lomb Incorporated
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-17 | Rayner Intraocular Lenses Limited | RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry o |
| 2017-09-01 | Aaren Scientific Inc. | The recommended storage temperature on the label is incorrect. |
| 2017-04-05 | Bausch & Lomb Surgical, Inc. | Complaints concerning kinked haptics that were occurring during lens delivery. |
| 2016-09-05 | Alcon Research, Ltd. | The intraocular lens could become lodged within the cartridge |
| 2003-08-18 | Beckman Coulter Inc | Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values. |
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