Recall Z-1269-2022 ยท HQL Intraocular Lens
Alcon Laboratories Ireland, Ltd
Alcon Clareon IOL with AutonoMe Delivery System
| Date | May 11, 2022 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On 05/11/2022, Alcon Laboratories sent an "URGENT: VOLUNTARY MEDICAL DEVICE REMOVAL" Letter via FedEx overnight informing customer that the firm has initiated a removal of one specific lot (25238769) of the Clareon IOL with AutonoMe Delivery System (CNA0T0.175). Based on the firm's investigation, there is the potential for limited number of 24.0D lenses to be included within this lot of the 17.5D Clareon IOL AutonoMe Delivery System. Customers are asked to locate and return the Alcon 17.5D Clareon IOL AutonoMe Delivery System with lot 25238769. An Alcon associate will reach out to customers |
| Quantity | 139 lenses (Lot 25238769) and 164 lenses (Lot 25238775) |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.