Recall Z-0028-2022 ยท MJP Lens, Intraocular, Toric Optics
Johnson & Johnson Surgical Vision Inc
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.
| Date | Aug 6, 2021 |
| Status | Terminated |
| Reason | Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance. |
| Root cause | Process control |
| Action | On 08/18/2021, the firm sent via FedEx standard overnight an "URGENT DEVICE Recall" Letter informing customers that it inadvertently release of nonconforming product (high endotoxin levels). Customers are instructed to: 1. Complete and return the Customer Reply Form to acknowledge receipt of the Recall Notice and email to RegCompliOne@its.jnj.com within 3 business days of receipt of the recall notice. 2. Review their patient records to confirm implantation of the impacted lens. 3. If no unexpected postoperative outcome occurred following implantation, no further action is required after Cust |
| Quantity | 1 lens |
| Distribution | U.S. Nationwide distribution in the state of IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.