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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0028-2022
Event ID88564
Event DescriptionTECNIS 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 TypeDevices
DistributionU.S. Nationwide distribution in the state of IL.
Quantity1 lens
Recall ReasonNonconforming 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 Classification20211013
Device Code InfoModel: DIU225U050 UDI Code: (01)05050474745831(17)240414(21)5248142104 Production Order Number: 900001985625 Serial Number: 5248142104
Center Classification Date20211004
Recall Initiation Date20210806
Recalling FirmJohnson & Johnson Surgical Vision Inc
Initial Notification Letter
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