Z-0470-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- September 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
Reason for Recall
Their is a potential that intraocular implant devices may not meet specifications.
Distribution Pattern
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
Code Information
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