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 | Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks. |
| Product | TECNIS Toric II OptiBlue IOL Models ZCW |
| Quantity | 36 |
| Distribution | International distribution to the country of Japan. |
| Initiated | 2023-12-12 |
| Classified | 2024-01-16 |
| Recall number | Z-0735-2024 |
| 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-0735-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93523/
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