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EVO/EVO+VISIAN Implantable Collamer Lens

STAAR SURGICAL COMPANY · Model VTICM5 13.7 (-6.0/1.5) · UDI-DI 00840311314744

QCB Prescription
0
510(k) clearances
18,233
Adverse events (1 deaths)
5
Recalls
3
Facilities

Description

VTICM5 - Diopter: -6.0; Cylinder 1.5; Overall Diameter (Length): 13.7

Recalls

DateFirmReason
2026-01-21Staar Surgical AGToric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potentia
2023-09-29Staar Surgical CompanyTheir is a potential that intraocular implant devices may not meet specifications.
2023-09-29Staar Surgical CompanyTheir is a potential that intraocular implant devices may not meet specifications.
2023-09-29Staar Surgical CompanyTheir is a potential that intraocular implant devices may not meet specifications.
2023-09-29Staar Surgical CompanyTheir is a potential that intraocular implant devices may not meet specifications.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.