FDA Device recall Z-0466-2024
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens by Staar Surgical, citing their is a potential that intraocular implant devices may not meet specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0466-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-29 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Staar Surgical |
| Distribution | 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 |
Product
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Reason
Their is a potential that intraocular implant devices may not meet specifications.
Identifiers
| code_info | Serial Number/UDI: S1721405/ (01)00841542119429(11)221031(17)240930(21)S1721405; S1746843/ (01)00841542119375(11)221120…Serial Number/UDI: S1721405/ (01)00841542119429(11)221031(17)240930(21)S1721405; S1746843/ (01)00841542119375(11)221120(17)241031(21)S1746843; S1721482/ (01)00841542119429(11)221031(17)240930(21)S1721482; S1765360/ (01)00841542119375(11)221205(17)241130(21)S1765360; S1957652/ (01)00841542119443(11)230515(17)250430(21)S1957652; S1765367/ (01)00841542119375(11)221205(17)241130(21)S1765367; S1879265/ (01)00841542119399(11)230317(17)250228(21)S1879265; S1855309/ (01)00841542119375(11)230223(17)250131(21)S1855309; S1721419/ (01)00841542119429(11)221031(17)240930(21)S1721419; S1749618/ (01)00841542119436(11)221121(17)241031(21)S1749618; S1758641/ (01)00841542119405(11)221128(17)241031(21)S1758641; S1957701/ (01)00841542119443(11)230515(17)250430(21)S1957701; S1760801/ (01)00841542119450(11)221130(17)241031(21)S1760801; S1765411/ (01)00841542119375(11)221205(17)241130(21)S1765411; S1669798/ (01)00841542119382(11)220922(17)240831(21)S1669798; S1724122/ (01)00841542119320(11)221102(17)241031(21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0466-2024%22
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