Home › Device types › KYB
Lens, Guide, Intraocular
FDA product code KYB · Class 1 · Ophthalmic
32
Registered devices
8,669
Adverse events
7
Recalls
39
510(k) clearances
Devices with this code
UNFOLDER SILVER — JOHNSON & JOHNSON SURGICAL VISION, INC.UNFOLDER EMERALD AR — JOHNSON & JOHNSON SURGICAL VISION, INC.VISCOJECT 1.8 Injector Set — Medicel AGDuckworth & Kent — DUCKWORTH AND KENT LIMITEDVISCOJECT 2.2 Injector Set — Medicel AGUNFOLDER SILVER — JOHNSON & JOHNSON SURGICAL VISION, INC.UNFOLDER EMERALD — JOHNSON & JOHNSON SURGICAL VISION, INC.MONARCH® III — Alcon Laboratories, Inc.MONARCH® II — Alcon Laboratories, Inc.UNFOLDER PLATINUM 1 SERIES — JOHNSON & JOHNSON SURGICAL VISION, INC.UNFOLDER EMERALD — JOHNSON & JOHNSON SURGICAL VISION, INC.Duckworth & Kent — DUCKWORTH AND KENT LIMITEDMicroStaar — STAAR SURGICAL COMPANYDuckworth & Kent — DUCKWORTH AND KENT LIMITEDUNFOLDER EMERALD — JOHNSON & JOHNSON SURGICAL VISION, INC.MSI Precision Specialty Instruments — Med Saver, Inc.MONARCH® II — Alcon Laboratories, Inc.Duckworth & Kent — DUCKWORTH AND KENT LIMITEDNucleus Chopper - Beckingsale — HURRICANE MEDICAL INCIOL Manipulator - Sinskey — HURRICANE MEDICAL INCIOL Glide - Sheets — HURRICANE MEDICAL INCIOL Manipulator - Sinskey — HURRICANE MEDICAL INCDuckworth & Kent — DUCKWORTH AND KENT LIMITEDIOL Manipulator - Lester — HURRICANE MEDICAL INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-13 | Alcon Research LLC | Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (I |
| 2016-05-02 | Staar Surgical Co. | The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses). |
| 2009-01-23 | Volk Optical Inc | Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the Ball-Seal bushing assembly. As a result, the set screw be |
| 2008-07-07 | Alcon Laboratories, Inc | Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens. |
| 2004-04-21 | Staar Surgical Co Inc | Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector. |
| 2004-02-23 | Staar Surgical Co Inc | Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use. |
| 2004-01-06 | Staar Surgical Co Inc | Increased numbers of lens tears during placement of lens into eye. |
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