TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simpli
Summary
The FDA issued a Class II for TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation by Johnson & Johnson Surgical Vision Inc. Reason: Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specifi.
Details
Source
Device Recall
External ID
Z-0028-2022
Action Date
2021-10-13
Status
Terminated
Category
device
Product 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.
Lot/Code Info: Model: DIU225U050 UDI Code: (01)05050474745831(17)240414(21)5248142104 Production Order Number: 900001985625 Serial Number: 5248142104
Quantity Affected: 1 lens
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.
Distribution
U.S. Nationwide distribution in the state of IL.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-06
Company
Santa Ana, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Johnson & Johnson Surgical Vision Inc has 13 FDA actions in our database, including 12 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Johnson & Johnson Surgical Vision Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Johnson & Johnson Surgical Vision Inc have FDA actions?
Johnson & Johnson Surgical Vision Inc has 13 FDA actions in our database, including 12 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0028-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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