FDA Device recall Z-0465-2024
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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_12.6. 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-0465-2024 |
| 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_12.6. Phakic Intraocular lens.
Reason
Their is a potential that intraocular implant devices may not meet specifications.
Identifiers
| code_info | Serial Number/UDI: S1731386/(01)00841542119214(11)221109(17)241031(21)S1731386; S1767226/(01)00841542119139(11)221207(1…Serial Number/UDI: S1731386/(01)00841542119214(11)221109(17)241031(21)S1731386; S1767226/(01)00841542119139(11)221207(17)241130(21)S1767226; S1829207/(01)00841542119146(11)230205(17)250131(21)S1829207; S1731401/(01)00841542119214(11)221109(17)241031(21)S1731401; S1731432/(01)00841542119214(11)221109(17)241031(21)S1731432; S1743481/(01)00841542119177(11)221117(17)241031(21)S1743481; S1767274/(01)00841542119139(11)221207(17)241130(21)S1767274; S1752570/(01)00841542119153(11)221123(17)241031(21)S1752570; S1743474/(01)00841542119177(11)221117(17)241031(21)S1743474; S1731493/(01)00841542119221(11)221109(17)241031(21)S1731493; S1752526/(01)00841542119153(11)221123(17)241031(21)S1752526; S1752533/(01)00841542119160(11)221123(17)241031(21)S1752533; S1752529/(01)00841542119153(11)221123(17)241031(21)S1752529; S1732703/(01)00841542119191(11)221110(17)241031(21)S1732703; S1767229/(01)00841542119139(11)221207(17)241130(21)S1767229; S1832551/(01)00841542119122(11)230208(17)250131(21)S1832551; S1743 |
|---|
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-0465-2024%22
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