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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 June 09, 2020
Create Date July 10, 2020
Recall Status1 Terminated 3 on February 11, 2021
Recall Number Z-2552-2020
Recall Event ID 85862
PMA Number P910056 
Product Classification intraocular lens - Product Code HQL
Product enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.
Code Information Model number: MX60ET, Catalog number: MXUET  Lot numbers: Lot Number 3043212   Serial Numbers: 3043212002 (UDI (01)10757770555199(17)230131(21)3043212002); 3043212005 (UDI (01)10757770555199(17)230131(21)3043212005); 3043212006 (UDI (01)10757770555199(17)230131(21)3043212006); 3043212007 (UDI (01)10757770555199(17)230131(21)3043212007); 3043212008 (UDI (01)10757770555199(17)230131(21)3043212008)
Recalling Firm/
Manufacturer		 Bausch & Lomb Surgical, Inc.
21 N Park Place Blvd
Clearwater FL 33759-3917
For Additional Information Contact
800-338-2020
Manufacturer Reason
for Recall		 The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action On 06/09/2020, BAUSCH and LOMB's Sales Representatives contacted customers by telephone and email. In addition, the firm sent a letter to customers dated, June 17, 2020 and titled, "MEDICAL DEVICE VOLUNTARY PRODUCT RECALL". The letter informs customers about a voluntary recall of one lot of enhanced enVista MX60ET intraocular lenses (IOLs). Customers should quarantine product and return product to the firm. Customers should complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact the firm to obtain a Return Material Authorization Number and arrange for pickup of the identified product. The contact information for Bausch and Lomb Surgical Customer Service is 1-800-338-2020, Customer Service (option 2).
Quantity in Commerce 5
Distribution U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.
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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