FDA Medical Device Recalls (openFDA)
Johnson & Johnson Surgical Vision, Inc.: TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
- Recall number
- Z-2289-2023
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc.
- Product
- TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
- Status
- Open, Classified
- Initiated
- 2023-07-06
- Posted
- 2023-08-03
- Terminated
- not on file
- Reason
- Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
- 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
- 61 units
- Distribution
- International distribution to the countries of China, India, Korea.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P980040S117"]
- Product code
- HQL
- Firm FEI
- 3012236936
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28