Single-Use Packs — Class II medical device recall Z-1007-2023
Ongoing recall by Johnson & Johnson Surgical Vision, Inc., reported 2023-02-01, distributed in FL, IL, MN, MS, NY, OH, TN, TX. Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which
| Recall number | Z-1007-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson & Johnson Surgical Vision, Inc., Irvine, CA, United States |
| Recall initiated | 2022-12-07 |
| Classified | 2023-01-20 |
| Reported by FDA | 2023-02-01 |
| Distributed | FL, IL, MN, MS, NY, OH, TN, TX |
| Countries outside the US | BE, CH, CN, DE, EE, FR, GB, ID, IT, JP, LK, MY, NL, PT, TH |
| Quantity | 384 |
| UPC / GTIN / UDI-DI | 05050474573352 |
| Lot numbers | 05050474573352/60326033 |
| Model numbers | OPO80 |
Product
Single-Use Packs, REF: OPO80
Reason for recall
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1007-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.