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 | Potential breach in the sterility barrier for tray ring covers. |
| Product | TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, |
| Quantity | N/A |
| Distribution | Worlwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, WA, WI and the countries of Chile, Indonesia, India, Japan, Malaysia, Philippines, Taiwan. |
| Initiated | 2022-04-06 |
| Classified | 2022-05-04 |
| Recall number | Z-1033-2022 |
| 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-1033-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89991/
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