FDA recall Z-1269-2022

Alcon Laboratories Ireland, Ltd · Class II · device

Product

Alcon Clareon IOL with AutonoMe Delivery System

Reason for recall

Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.

Distribution

U.S.: AL, CA, FL, GA, IA, IL, KY, LA, MI, MO, NY, OH,OK, TX, VA, and WI O.U.S.: Czech Republic, France, Germany, India, Slovakia, Spain, and Switzerland

Key facts

Status: Terminated
Initiation date: 2022-05-11
Report date: 2022-06-29
Termination date: 2025-02-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cork, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1269-2022