FDA Recall
Open, Classified
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Recall: Z-0260-2024
·
Initiated September 7, 2023
Recall
- Recall Number
- Z-0260-2024
- Event Number
- 93115
- Firm
- Alcon Research, LLC
- FEI Number
- 1000117501
- Product Code
- LRO
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 7, 2023
- Posted
- November 7, 2023
- Address
- 9965 Buffalo, Speedway Houston, TX, 77054-1309
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".
Action
On September 7, 2023, Alcon contacted consignees by phone to notify them of the recall. Alcon asked consignees to take the following action: 1. Discontinue using the affected lot and requested the customer confirm any quantity of remaining units in order to start the return process for any unused custom paks.
Distribution
US: VA OUS: None
Quantity
120 packs