Recall archive / FDA device enforcement
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR — FDA record Z-0260-2024
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 Sep 7, 2023. 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
- Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
- Reason
- Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
- Classification
- Class II
- Recalling firm
- Alcon Research, LLC
- Quantity
- 120 packs
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0260-2024
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 | LOT # : 160NMU, UDI: (01)10380653302278 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: VA OUS: None
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
- Nov 15, 2023
- Recall initiation date
- Sep 7, 2023
- Center classification date
- Nov 7, 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.