Device product
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Z-0260-2024
Product summary
- Event
- Event 93115
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 120 packs
- Official record key
device-enforcement:Z-0260-2024
Official wording
Reason: Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
Code information: LOT # : 160NMU, UDI: (01)10380653302278
Distribution pattern: US: VA OUS: None
Derived failure modes
-
Unknown
Custom surgical procedure packs contain latex gloves but are labeled as "latex free".