Class II — Johnson & Johnson Surgical Vision, Inc.
| Recalling firm | Johnson & Johnson Surgical Vision, Inc. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks. |
| Product | TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only |
| Quantity | 61 units |
| Distribution | International distribution to the countries of China, India, Korea. |
| Initiated | 2023-07-06 |
| Classified | 2023-08-03 |
| Recall number | Z-2289-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Johnson & Johnson Surgical Vision, Inc. (Z-2289-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92666/
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