Johnson & Johnson Surgical Vision Inc Recall 88564
Description: 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.
Johnson & Johnson Surgical Vision Inc Recall 88564 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0028-2022 |
| Event ID | 88564 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the state of IL. |
| Quantity | 1 lens |
| Recall 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. |
| Device Classification | 20211013 |
| Device Code Info | Model: DIU225U050 UDI Code: (01)05050474745831(17)240414(21)5248142104 Production Order Number: 900001985625 Serial Number: 5248142104 |
| Center Classification Date | 20211004 |
| Recall Initiation Date | 20210806 |
| Recalling Firm | Johnson & Johnson Surgical Vision Inc |
| Initial Notification | Letter |
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