Recall Z-0519-2021 ยท MJP Lens, Intraocular, Toric Optics
Bausch & Lomb Surgical, Inc.
MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
| Date | Nov 7, 2020 |
| Status | Terminated |
| Reason | Product may be missing toric axis marks. |
| Root cause | Process change control |
| Action | The 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 | 31 devices |
| Distribution | US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.