FDA Enforcement
Class II
Ongoing
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Recall: Z-0260-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0260-2024
- Event ID
- 93115
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Alcon Research, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- November 15, 2023
- Initiation Date
- September 7, 2023
- Classification Date
- November 7, 2023
- Address
- 9965 Buffalo Speedway, Houston, TX, 77054-1309, United States
Description
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".
Code Info
LOT # : 160NMU, UDI: (01)10380653302278
Distribution
US: VA OUS: None
Quantity
120 packs