medical Class II Updated 2018-12-26

Bausch & Lomb Surgical, Inc. recalls enVista One Piece Hydrophobic Acrylic Intraocular lens -

Recalled Product

enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag.

Hazard / Issue

Cosmetic imperfections on the surface of some lenses.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Model MX60E and specific lots of the following SKU's: MXUE0000, MXUE0100, MXUE0200, MXUE0300, MXUE0400, MXUE0500, MXUE0600, MXUE0700, MXUE0800, MXUE0900, MXUE1000, MXUE1050, MXUE1100, MXUE1150, MXUE1200, MXUE1250, MXUE1300, MXUE1350, MXUE1400, MXUE1450, MXUE1500, MXUE1550, MXUE1600, MXUE1650, MXUE1700, MXUE1750, MXUE1800, MXUE1850, MXUE1900, MXUE1950, MXUE2000, MXUE2050, MXUE2100, MXUE2150, MXUE2200, MXUE2250, MXUE2300, MXUE2350, MXUE2400, MXUE2450, MXUE2500, MXUE2550, MXUE2600, MXUE2650, MXUE2700, MXUE2750, MXUE2800, MXUE2850, MXUE2900, MXUE2950, MXUE3000, MXUE3100, MXUE3200, MXUE3300, and MXUE3400.

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