Lens, Guide, Intraocular

Brand Name: Alcon

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 (IOL) upon delivery.

Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.

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 becomes disengaged from the set screw groove in the bushing assembly and the Lens Positioning Unit slides downward.

MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Wor

Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.

MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF

Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.

MicroSTAAR Injector, MSI-PF

Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.

MicroSTAAR Injector Cartridges Models:

Increased numbers of lens tears during placement of lens into eye.

STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.

The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).