Bausch & Lomb Surgical, Inc. 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.

Recommended Action

Per FDA guidance

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).