Recall Z-2552-2020 ยท HQL Intraocular Lens
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.
| Date | Jun 9, 2020 |
| Status | Terminated |
| Reason | The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens. |
| Root cause | 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 |
| Quantity | 5 |
| Distribution | U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.