Alcon Clareon IOL with AutonoMe Delivery System recalled over labeling errors
- Recall date
- May 11, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Alcon Laboratories Ireland, Ltd recalls Alcon Clareon IOL with AutonoMe Delivery System
- Recall number
- Z-1269-2022
- FDA classification
- Class II
- Brand / firm
- Alcon Laboratories Ireland, Ltd
- Sold / distributed
- 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
Why it was recalled
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Alcon Clareon IOL with AutonoMe Delivery System
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