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.
FDA Recall Z-0628-2019 · Posted None
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Recalling FirmBausch & Lomb Surgical, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2018-11-05
Date Terminated2019-11-04
Product Quantity70,440 units
Reason for Recall
Cosmetic imperfections on the surface of some lenses.
Firm Action
On Nov 5, 2018 Bausch & Lomb sent letters to all their consignees, requesting the following;
1. Review and quarantine your inventory of all the impacted lots for this recall.
2. Complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact B&L to obtain a return material authorization number and arrange for a pick up of the identified product. Contact 800-338-2020 option 2.
If you have any questions, contact the Quality Manager at 727-724-6695.
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL IN, KS, KY, la, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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