FDA Device recall Z-0472-2024
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric 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: VTICM5_13.2. Phakic Toric 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-0472-2024 |
| 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: VTICM5_13.2. Phakic Toric Intraocular lens.
Reason
Their is a potential that intraocular implant devices may not meet specifications.
Identifiers
| code_info | T1307122/ (01)00841542116152(11)230109(17)241231(21)T1307122; T1485436/ (01)00841542115735(11)230503(17)250430(21)T1485…T1307122/ (01)00841542116152(11)230109(17)241231(21)T1307122; T1485436/ (01)00841542115735(11)230503(17)250430(21)T1485436; T1257531/ (01)00841542116169(11)221122(17)241031(21)T1257531; T1365550/ (01)00841542115933(11)230214(17)250131(21)T1365550; T1511722/ (01)00841542116053(11)230522(17)250430(21)T1511722; T1187957/ (01)00841542116299(11)220926(17)240831(21)T1187957; T1342243/ (01)00841542116992(11)230131(17)241231(21)T1342243; T1367644/ (01)00841542116305(11)230216(17)250131(21)T1367644; T1205475/ (01)00841542116763(11)221010(17)240930(21)T1205475; T1387400/ (01)00841542116411(11)230301(17)250131(21)T1387400; T1228382/ (01)00841542116534(11)221030(17)240930(21)T1228382 |
|---|
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-0472-2024%22
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