FDA Enforcement
Class II
Ongoing
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
Recall: Z-0473-2024
·
Reported December 13, 2023
Enforcement
- Recall Number
- Z-0473-2024
- Event ID
- 93312
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Staar Surgical Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- December 13, 2023
- Initiation Date
- September 29, 2023
- Classification Date
- December 1, 2023
- Address
- 1911 Walker Ave, Monrovia, CA, 91016-4846, United States
Description
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
Reason
Their is a potential that intraocular implant devices may not meet specifications.
Code Info
T1438478/ (01)00841542118378(11)230331(17)250228(21)T1438478; T1224985/ (01)00841542118316(11)221026(17)240930(21)T1224985; T1259704/ (01)00841542118330(11)221126(17)241031(21)T1259704; T1370322/ (01)00841542118347(11)230218(17)250131(21)T1370322; T1508546/ (01)00841542118644(11)230518(17)250430(21)T1508546; T1299195/ (01)00841542118149(11)221231(17)241130(21)T1299195
Distribution
US: 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 OUS: None
Quantity
6 UNITS