Device product
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Z-0468-2024
Product summary
- Event
- Event 93312
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 UNIT
- Official record key
device-enforcement:Z-0468-2024
Official wording
Reason: Their is a potential that intraocular implant devices may not meet specifications.
Code information: UDI:(01)00841542121972/ Serial Number: S1734493
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