ClearanceBrief
Panels › Ophthalmic › Product code KYB · Class 1

Lens, Guide, Intraocular

Regulation 886.4300

0510(k)s in 12 months (39 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
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Top companies in KYB

Company510(k)sRecalls
STAAR Surgical Company74
Alcon Laboratories31
Alcon Research, Ltd.11
Allergan Medical Optics20
Chiron Ophthalmics20
Chiron Vision Corp.20
CooperVision, Inc.20
Duckworth & Kent, Ltd.20
Alcon Manufacturing, Ltd.10
Allergan, Inc.10
DateFirm and productCodeLinked 510(k)
Jan 10, 2025Alcon Research LLC
Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A
Open, Classified		 KYBK063155
May 2, 2016Staar Surgical Co.
STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
Terminated		 KYBK940593
Jul 14, 2009Volk Optical Inc
Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.
Terminated		 KYBNone listed
Sep 23, 2008Alcon Laboratories, Inc
MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof IOLs*
Terminated		 KYBK001157
Jul 20, 2004Staar Surgical Co Inc
MicroSTAAR Injector, MSI-PF Packed ten per box.
Terminated		 KYBK980696
Jul 20, 2004Staar Surgical Co Inc
MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF
Terminated		 KYBNone listed
Jan 29, 2004Staar Surgical Co Inc
MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens)
Terminated		 KYBNone listed

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