FDA recall Z-0260-2024

Alcon Research, LLC · Class II · device

Product

Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR

Reason for recall

Custom surgical procedure packs contain latex gloves but are labeled as "latex free".

Distribution

US: VA OUS: None

Key facts

Status: Ongoing
Initiation date: 2023-09-07
Report date: 2023-11-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0260-2024