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Recall Observatory FDA recall evidence

Device product

EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.

Z-0468-2024

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-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

    reason.potency_specification_failure · v1.0.0

    may not meet specifications