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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 enVistasee related information
Date Initiated by FirmNovember 07, 2020
Create DateDecember 02, 2020
Recall Status1 Terminated 3 on July 11, 2024
Recall NumberZ-0519-2021
Recall Event ID 86721
PMA NumberP910056S036 
Product Classification Lens, intraocular, toric optics - Product Code MJP
ProductMX60ET (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
Manufacturer Reason
for Recall		Product may be missing toric axis marks.
FDA Determined
Cause 2		Process change control
ActionThe 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 Commerce31 devices
DistributionUS Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = MJP
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