Cork, Ireland
Alcon Laboratories Ireland, Ltd recalls
1 recall recorded since 2018, most recently on 11 May 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 May 2022
- Terminated
- 5 February 2025
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1269-2022
- Alcon Clareon IOL with AutonoMe Delivery System
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.