Date Initiated by Firm |
November 07, 2020 |
Create Date |
December 02, 2020 |
Recall Status1 |
Completed |
Recall Number |
Z-0519-2021 |
Recall Event ID |
86721 |
PMA Number |
P910056S036 |
Product Classification |
Lens, intraocular, toric optics - Product Code MJP
|
Product |
MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
|
Code Information |
Lot number: 3043816 Serial numbers: 3043816001 3043816002 3043816003 3043816004 3043816005 3043816006 3043816007 3043816008 3043816009 3043816010 3043816011 3043816012 3043816013 3043816014 3043816015 3043816016 3043816017 3043816018 3043816019 3043816020 3043816023 3043816024 3043816025 3043816026 3043816027 3043816028 3043816029 3043816030 3043816031 |
Recalling Firm/ Manufacturer |
Bausch & Lomb Surgical, Inc. 21 N Park Place Blvd Clearwater FL 33759-3917
|
For Additional Information Contact |
727-724-6600
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Manufacturer Reason for Recall |
Product may be missing toric axis marks.
|
FDA Determined Cause 2 |
Process change control |
Action |
The firm initiated the recall by letter on 11/07/2020. The letter requested the consignee review their inventory and quarantine all suspect product. It further requested that the consignee complete the acknowledgement form and contact Bausch & Lomb to obtain a Return Material Authorization Number and arrange for pick up of the devices. Those with questions or concerns regarding the process should call 1-800-338-2020. |
Quantity in Commerce |
31 devices |
Distribution |
US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH. |
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.
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PMA Database |
PMAs with Product Code = MJP and Original Applicant = Bausch & Lomb, Inc.
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