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.
FDA Recall Z-2552-2020 · Posted None
Recalling FirmBausch & Lomb Surgical, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2020-06-09
Date Terminated2021-02-11
Product Quantity5
Reason for Recall
The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
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).
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.