Panels › Ophthalmic › Product code MSS · Class 1
Folders And Injectors, Intraocular Lens (Iol)
Regulation 886.4300
1510(k)s in 12 months (63 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in MSS
| Company | 510(k)s | Recalls |
|---|---|---|
| Bausch & Lomb | 11 | 0 |
| Lenstec, Inc. | 5 | 0 |
| Medicel AG | 5 | 0 |
| Rayner Intraocular Lenses , Ltd. | 4 | 1 |
| Rxsight, Inc. | 5 | 0 |
| STAAR Surgical Company | 5 | 0 |
| Ast Products, Inc. | 4 | 0 |
| Alcon Research, Ltd. | 2 | 1 |
| Duckworth & Kent, Ltd. | 3 | 0 |
| Rayner Surgical, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2020 | Rayner Intraocular Lenses Limited RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those Open, Classified |
MSS | K141091 |
| Sep 1, 2017 | Aaren Scientific Inc. AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA.
Used to fold and insert the fir Terminated |
MSS | K123888 |
| Apr 5, 2017 | Bausch & Lomb Surgical, Inc. SoftPort Easy-Load Lens Delivery System Model: EZ-28V
Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System co Terminated |
MSS | K970727 |
| Jan 9, 2017 | Alcon Research, Ltd. Alcon Monarch III (1) "C" Cartridge
The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal Terminated |
MSS | K112977 |
| Jul 23, 2004 | Beckman Coulter Inc Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent. Terminated |
MSS | K010748 K973696 |
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