Device product
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Z-0467-2024
Product summary
- Event
- Event 93312
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0467-2024
Official wording
Reason: Their is a potential that intraocular implant devices may not meet specifications.
Code information: UDI:(01)00841542119696(11)221031(17)240930(21)S1721962/ Serial Number: S1721962
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