Recall archive / FDA device enforcement
FUSION Dual Pump Packs, REF: OPO73 — FDA record Z-1006-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 7, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- FUSION Dual Pump Packs, REF: OPO73
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc.
- Quantity
- 7644
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1006-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI/Lots: 15050474602080/60373238, 60394037, 60308197 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, United Kingdom
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 1, 2023
- Recall initiation date
- Dec 7, 2022
- Center classification date
- Jan 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.