| Class 2 Device Recall enVista | |
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
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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
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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 |
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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.
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PMA Database | PMAs with Product Code = HQL
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