FDA Device recall Z-0474-2024
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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: VICMO12.6. 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-0474-2024 |
| 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: VICMO12.6. Phakic Intraocular lens.
Reason
Their is a potential that intraocular implant devices may not meet specifications.
Identifiers
| code_info | Serial/UDI: S1746728/ (01)00841542122023(11)221120(17)241031(21)S1746728; S1713542/ (01)00841542122030(11)221026(17)240…Serial/UDI: S1746728/ (01)00841542122023(11)221120(17)241031(21)S1746728; S1713542/ (01)00841542122030(11)221026(17)240930(21)S1713542; S1746725/ (01)00841542122016(11)221120(17)241031(21)S1746725; S1707067/ (01)00841542122016(11)221022(17)240930(21)S1707067; S1734035/ (01)00841542122047(11)221111(17)241031(21)S1734035; S1713494/ (01)00841542122030(11)221026(17)240930(21)S1713494; S1713551/ (01)00841542122030(11)221026(17)240930(21)S1713551; S1740887/ (01)00841542122047(11)221115(17)241031(21)S1740887; S1713505/ (01)00841542122030(11)221026(17)240930(21)S1713505 |
|---|
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-0474-2024%22
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