FDA Device recall Z-0464-2024
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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_12.1. 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-0464-2024 |
| 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_12.1. Phakic Intraocular lens.
Reason
Their is a potential that intraocular implant devices may not meet specifications.
Identifiers
| code_info | Serial/UDI: S1894967/(01)00841542118965(11)230330(17)250228(21)S1894967; S1954863/(01)00841542118958(11)230513(17)2504…Serial/UDI: S1894967/(01)00841542118965(11)230330(17)250228(21)S1894967; S1954863/(01)00841542118958(11)230513(17)250430(21)S1954863; S1725689/(01)00841542118910(11)221103(17)241031(21)S1725689; S1725624/(01)00841542118873(11)221103(17)241031(21)S1725624; S1771602/(01)00841542118927(11)221214(17)241130(21)S1771602; S1725625/(01)00841542118873(11)221103(17)241031(21)S1725625; S1847793/(01)00841542119030(11)230218(17)250131(21)S1847793; S1725627/(01)00841542118873(11)221103(17)241031(21)S1725627; S1901889/(01)00841542118873(11)230404(17)250331(21)S1901889; S1771554/(01)00841542118873(11)221214(17)241130(21)S1771554; S1699274/(01)00841542118972(11)221016(17)240930(21)S1699274; S1877126/(01)00841542118965(11)230313(17)250228(21)S1877126; S1771633/(01)00841542119030(11)221214(17)241130(21)S1771633; S1744475/(01)00841542118910(11)221119(17)241031(21)S1744475; S1863018/(01)00841542118873(11)230302(17)250228(21)S1863018; S1734365/(01)00841542118934(11)221112(17)241031(21)S1734365; S1877112/(0 |
|---|
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-0464-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.