FDA Device recall Z-0470-2024
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. 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_12.1. 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-0470-2024 |
| 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_12.1. Phakic Toric Intraocular lens.
Reason
Their is a potential that intraocular implant devices may not meet specifications.
Identifiers
| code_info | Serial/UDI: T1366733/(01)00841542113809(11)230215(17)250131(21)T1366733; T1485721/(01)00841542113892(11)230503(17)2504…Serial/UDI: T1366733/(01)00841542113809(11)230215(17)250131(21)T1366733; T1485721/(01)00841542113892(11)230503(17)250430(21)T1485721; T1347685/(01)00841542113700(11)230203(17)250131(21)T1347685 |
|---|
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-0470-2024%22
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