Device product

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.

Z-0470-2024

September 29, 2023

Class II

Product summary

Firm: Staar Surgical Company
Event: Event 93312
Status: Ongoing
Classification: Class II
Quantity: 3 units
Official record key: device-enforcement:Z-0470-2024

Official wording

Reason: Their is a potential that intraocular implant devices may not meet specifications.

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

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
reason.potency_specification_failure · v1.0.0

may not meet specifications