Z-0028-2022Class II

TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The...

Name: Z-0028-2022 TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The...
Creator: Johnson & Johnson Surgical Vision Inc
Published: 2021-08-06
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2021-08-06 / Terminated / root cause: manufacturing process

FDA source

Johnson & Johnson Surgical Vision Inc began a recall of TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a... on 2021-08-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0028-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-06
Posted: 2021-10-04
Terminated: 2023-03-06
Recalling firm: Advanced Medical Optics, Inc.
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.
Product code: MJP Lens, Intraocular, Toric Optics
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 [email protected]
Quantity in commerce: 1 lens
Distribution: U.S. Nationwide distribution in the state of IL.
Product codes and lots: Model: DIU225U050 UDI Code: (01)05050474745831(17)240414(21)5248142104 Production Order Number: 900001985625 Serial Number: 5248142104

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0028-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0028-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-04

Product code MJP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)