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U.S. Department of Health and Human Services

Class 2 Device Recall TECNIS EyhanceTM Toric II IOLs with TECNIS Simplicity" Delivery System/Model Number DIU225U050)

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  Class 2 Device Recall TECNIS EyhanceTM Toric II IOLs with TECNIS Simplicity" Delivery System/Model Number DIU225U050) see related information
Date Initiated by Firm August 06, 2021
Create Date October 04, 2021
Recall Status1 Open3, Classified
Recall Number Z-0028-2022
Recall Event ID 88564
PMA Number P980040S117 
Product Classification Lens, intraocular, toric optics - Product Code MJP
Product 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.
Code Information Model: DIU225U050 UDI Code: (01)05050474745831(17)240414(21)5248142104 Production Order Number: 900001985625 Serial Number: 5248142104
Recalling Firm/
Manufacturer
Johnson & Johnson Surgical Vision Inc
1700 E Saint Andrew Pl
Santa Ana CA 92705-4933
For Additional Information Contact Jodi Turpin-Swindle
949-480-7526
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 Customer Reply Form has been returned. 4. If issues were encountered, inform the Recall Firm by calling 877-266-4543, Option 2. If reporting a complaint, provide the serial number, the date of surgery, a description of the event, and patient outcome. For any questions, contact Customer Support at; 877-266-4543, Option 2 or email RegCompliOne@its.jnj.com
Quantity in Commerce 1 lens
Distribution U.S. Nationwide distribution in the state of IL.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MJP and Original Applicant = Johnson & Johnson Surgical Vision, Inc.
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