Recall Z-2289-2023 ยท HQL Intraocular Lens
Johnson & Johnson Surgical Vision, Inc.
TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
| Date | Aug 3, 2023 (initiated Jul 6, 2023) |
| Status | Open, Classified |
| Reason | Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks. |
| Root cause | Under Investigation by firm |
| Action | On June 07, 20223, Johnson & Johnson Vison issued an "Urgent: Medical Device Recall" notice to affected consignees. Consignees were asked to take the following actions: 1. Identify if any of your inventory contains TECNIS IOLs from the list on pages 5-6 (see page 4 for label examples). 2. Remove all affected TECNIS IOLs from your inventory. No other TECNIS IOLs are affected by this recall. 3. Complete the attached Customer Reply Form (on page 3). We require this information for reconciliation purposes with regulatory agencies, even if you have no inventory. 4. Follow the specific instruct |
| Quantity | 61 units |
| Distribution | International distribution to the countries of China, India, Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.