Skip to content
Recall Observatory FDA recall evidence

Device product

EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.

Z-0467-2024

September 29, 2023

Class II

Product summary

Firm
Staar Surgical Company
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

    reason.potency_specification_failure · v1.0.0

    may not meet specifications