FDAMay 11, 2022device
Alcon Clareon IOL with AutonoMe Delivery System
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
What to do
FDA enforcement status: Terminated
Brands named
alcon laboratories irelandalconalcon laboratories
UPCs
00380652393669252387690000038065239379925238775000
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMinocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-302026-06-01
- FDAAmlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.2026-05-05
- FDAAscend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.2026-04-27
- FDAGenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.2026-04-21
- FDASystane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-012026-04-21
- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.2026-04-03
- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.2026-04-03
- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.2026-04-03
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