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U.S. Department of Health and Human Services

Class 2 Device Recall enVista

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  Class 2 Device Recall enVista see related information
Date Initiated by Firm November 05, 2018
Create Date December 18, 2018
Recall Status1 Terminated 3 on November 04, 2019
Recall Number Z-0628-2019
Recall Event ID 81600
PMA Number P910056 
Product Classification intraocular lens - Product Code HQL
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.
Code Information 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.  
Recalling Firm/
Manufacturer		 Bausch & Lomb Surgical, Inc.
21 N Park Place Blvd
Clearwater FL 33759-3917
For Additional Information Contact
727-724-6600
Manufacturer Reason
for Recall		 Cosmetic imperfections on the surface of some lenses.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 70,440 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = HQL and Original Applicant = Bausch & Lomb, Inc.
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