Drug recall
FUSION Dual Pump Packs, REF: OPO73
FDA recall event 91290 · Class II · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Event ID | 91290 |
|---|---|
| Recall numbers | Z-1005-2023, Z-1006-2023, Z-1007-2023 |
| Recalling firm | Johnson & Johnson Surgical Vision, Inc. |
| Product type | Devices |
| Products | FUSION Dual Pump Packs, REF: OPO73, Single-Use Packs, REF: OPO80, Veritas Advanced Infusion Packs, REF: VRT-AI |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Dec 7, 2022 |
| Report date | Feb 1, 2023 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3012236936 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: