Z-2289-2023Class II

TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

Name: Z-2289-2023 TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Creator: Johnson & Johnson Surgical Vision, Inc.
Published: 2023-07-06
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2023-07-06 / Open, Classified / root cause: manufacturing process

FDA source

Johnson & Johnson Surgical Vision, Inc. began a recall of TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only on 2023-07-06. FDA classified it as Class II and gives the reason as "Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2289-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-06
Posted: 2023-08-03
Recalling firm: Advanced Medical Optics, Inc.
Product: TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Product code: HQL Intraocular Lens
Reason for recall: Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On June 07, 20223, Johnson & Johnson Vison issued an "Urgent: Medical Device Recall" notice to affected consignees. Consignees were asked to take the following actions: 1. Identify if any of your inventory contains TECNIS IOLs from the list on pages 5-6 (see page 4 for label examples). 2. Remove all affected TECNIS IOLs from your inventory. No other TECNIS IOLs are affected by this recall. 3. Complete the attached Customer Reply Form (on page 3). We require this information for reconciliation purposes with regulatory agencies, even if you have no inventory. 4. Follow the specific instructions included in the letter "If you have product to be returned" or "If you do not have product to be returned" 5. Share this notice with anyone within your organization that needs to be informed and to any organization where the potentially affected products have been transferred. 6. If you have product complaints or adverse events to report regarding the use of the affected TECNIS IOLs, please inform Johnson & Johnson Vision. If you do report a complaint, please provide the TECNIS IOL serial number and, if a patient was involved, the date of surgery, a description of the event and patient outcome. 7. In addition, you may report any adverse events experienced or quality issues with the use of the TECNIS IOLs to the FDA's MedWatch Adverse Event Reporting program by phone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch/report.htm.
Quantity in commerce: 61 units
Distribution: International distribution to the countries of China, India, Korea.
Product codes and lots: UDI-DI: N/A/ Serial Numbers: 8046642236, 8046652236, 8046662236, 8046672236, 8046682236, 8046692236, 8046702236, 8046712236, 8046722236, 8046732236, 8046742236, 8046752236, 8046762236, 8046772236, 8046782236, 8046792236, 8046802236, 8046812236, 8046822236, 8046832236, 8046842236, 8046852236, 8046862236, 8046872236, 8046882236, 8046892236, 8046902236, 8046912236, 8046922236, 8046932236, 8046942236, 8046952236, 8046962236, 8046972236, 8046982236, 8046992236, 8047002236, 8047012236, 8047022236, 8047032236, 8047042236, 8047052236, 8047062236, 8047072236, 8047082236, 8047102236, 8047112236, 8047122236, 8047132236, 8047142236, 8047152236, 8047162236, 8047172236, 8047182236, 8047192236, 8047202236, 8047212236, 8047222236, 8047232236, 8047242236, 8047252236

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2289-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2288-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2289-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03

Product code HQL

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)