Home › STAAR SURGICAL COMPANY › EVO/EVO+VISIAN Implantable Collamer Lens
EVO/EVO+VISIAN Implantable Collamer Lens
STAAR SURGICAL COMPANY · Model VTICM5 13.7 (-6.0/4.0) · UDI-DI 00840311316144
QCB
Prescription
0
510(k) clearances
18,233
Adverse events (1 deaths)
5
Recalls
3
Facilities
Description
VTICM5 - Diopter: -6.0; Cylinder 4.0; Overall Diameter (Length): 13.7
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-21 | Staar Surgical AG | Toric 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 |
| 2023-09-29 | Staar Surgical Company | Their is a potential that intraocular implant devices may not meet specifications. |
| 2023-09-29 | Staar Surgical Company | Their is a potential that intraocular implant devices may not meet specifications. |
| 2023-09-29 | Staar Surgical Company | Their is a potential that intraocular implant devices may not meet specifications. |
| 2023-09-29 | Staar Surgical Company | Their is a potential that intraocular implant devices may not meet specifications. |
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Get your free API keyRead the docsData 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.
