Recall Z-0467-2024 ยท MTA Lens, Intraocular, Phakic
Staar Surgical Company
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
| Date | Dec 1, 2023 (initiated Sep 29, 2023) |
| Status | Open, Classified |
| Reason | Their is a potential that intraocular implant devices may not meet specifications. |
| Root cause | Software design (manufacturing process) |
| Action | On October 25, 2023, Staar Surgical issued a "Urgent: Medical Device Voluntary Recall" notification to affected consignees. Staar Surgical ask consignees to take the following actions: 1. Review your current inventory of STAAR EVO/EVO+ devices. 2. If any of the devices identified in the Medical Device Recall Return Response form have not already been implanted, please remove them from your inventory and quarantine the product. 3. Complete the Medical Device Recall Return Response form indicating if each device has been implanted or is in your possession. 4. Fax the form within 5 days upon |
| Quantity | 1 unit |
| Distribution | US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.