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EVO/EVO+VISIAN Implantable Collamer Lens

STAAR SURGICAL COMPANY · Model VICM5 12.6 (-12.5) · UDI-DI 00840311300655

MTA Prescription
0
510(k) clearances
21,997
Adverse events (2 deaths)
8
Recalls
5
Facilities

Description

VICM5 - Diopter: -12.5; Overall Diameter (Length): 12.6

Recalls

DateFirmReason
2026-04-20Staar Surgical AGDue to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
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.
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.