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Recall Observatory FDA recall evidence

Device product

EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.

Z-0473-2024

September 29, 2023

Class II

Product summary

Firm
Staar Surgical Company
Event
Event 93312
Status
Ongoing
Classification
Class II
Quantity
6 UNITS
Official record key
device-enforcement:Z-0473-2024

Official wording

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

Code information: T1438478/ (01)00841542118378(11)230331(17)250228(21)T1438478; T1224985/ (01)00841542118316(11)221026(17)240930(21)T1224985; T1259704/ (01)00841542118330(11)221126(17)241031(21)T1259704; T1370322/ (01)00841542118347(11)230218(17)250131(21)T1370322; T1508546/ (01)00841542118644(11)230518(17)250430(21)T1508546; T1299195/ (01)00841542118149(11)221231(17)241130(21)T1299195

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