Recall Z-0628-2019— Bausch & Lomb Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Bausch & Lomb Surgical, Inc., initiated 2018-11-05, terminated 2019-11-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Cosmetic imperfections on the surface of some lenses..
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-05
- Terminated
- 2019-11-04
- Firm location
- Clearwater, FL, United States
Product description
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.
Reason for recall
Cosmetic imperfections on the surface of some lenses.
Data sourced from openFDA. This site is unofficial and independent of the FDA.