EVO+VISIAN Implantable Collamer Lens — Class II medical device recall Z-0471-2024
Ongoing recall by Staar Surgical Company, reported 2023-12-13, distributed in AR, AZ, CA, CO, CT, FL, GA, HI…. Their is a potential that intraocular implant devices may not meet specifications.
| Recall number | Z-0471-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Staar Surgical Company, Monrovia, CA, United States |
| Recall initiated | 2023-09-29 |
| Classified | 2023-12-01 |
| Reported by FDA | 2023-12-13 |
| Distributed | 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 |
| Quantity | 15 units |
| UPC / GTIN / UDI-DI | 00841542114141, 00841542114349, 00841542114530, 00841542114615, 00841542114776, 00841542114950, 00841542114981, 00841542115209, 00841542115247, 00841542115384, 00841542115469, 00841542115506, 00841542115537, 00841542115544 |
Product
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
Reason for recall
Their is a potential that intraocular implant devices may not meet specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0471-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.