Device product
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Z-0469-2024
Product summary
- Event
- Event 93312
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0469-2024
Official wording
Reason: Their is a potential that intraocular implant devices may not meet specifications.
Code information: Serial Number/UDI: S1723954/(01)00841542122061(11)221101(17)240930(21)S1723954; S1723955/(01)00841542122061(11)221101(17)240930(21)S1723955;
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
Derived failure modes
-
Potency or specification failure
may not meet specifications