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.
- Company
- Bausch & Lomb Surgical, Inc.
- Recall Initiated
- November 5, 2018
- Terminated
- November 4, 2019
- Recall Number
- Z-0628-2019
- Quantity
- 70,440 units
- Firm Location
- Clearwater, FL
Reason for Recall
Cosmetic imperfections on the surface of some lenses.
Distribution
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.
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.
Root Cause
Process control
Action Taken
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.