Reported Jun 29, 2022 · Terminated
Alcon Clareon IOL with AutonoMe Delivery System
Alcon Laboratories Ireland, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Laboratories Ireland, Ltd · Cork Business And Technology Park · Cork · N/A
Is this the product you have?
- Alcon Clareon IOL with AutonoMe Delivery System
- Lot codes and dates
- Catalog/Model NumberCNA0T0.175
- UDI Code(01) 00380652393669 (17) 240720 (21) 25238769000 (11) 210722 (240)
- CNA0T0175 Lot number25238769
- Catalog/Model NumberCNA0T0.240
- UDI Code(01) 00380652393799 (17) 240720 (21) 25238775000 (11) 210722 (240)
- CNA0T0240 Lot Number25238775
- Amount recalled
- 139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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