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EVO/EVO+VISIAN Implantable Collamer Lens

FDA UDIEUDAMED

Class III (US FDA UDI)

Ref VTICM5 13.2

by Staar Surgical Co.

Identity

Trade Name
EVO+ Visian Toric ICL EUDAMED
EVO/EVO+VISIAN Implantable Collamer Lens FDA UDI
Generic Name
Posterior-chamber intraocular lens, phakic FDA UDI
Device Name
Implantable Collamer Lens EUDAMED
VTICM5 - Diopter: -13.0; Cylinder 1.5; Overall Diameter (Length): 13.2 FDA UDI
Model / Reference
VTICM5 13.2 EUDAMED
VTICM5 13.2 (-13.0/1.5) FDA UDI
Description
VTICM5 - Diopter: -13.0; Cylinder 1.5; Overall Diameter (Length): 13.2 FDA UDI

Identifiers

Catalog Number
VTICM5 13.2 FDA UDI
Primary DI / UDI-DI
00840311311521 EUDAMEDFDA UDI
Basic UDI-DI
764013516ICLGV EUDAMED
PMA Number
P030016 FDA UDI
FDA Product Code
QCB FDA UDI
EMDN Code
P030101030399 IOLs, PHAKIC, MONOFOCAL, TORIC - OTHER EUDAMED
GMDN Term
Posterior-chamber intraocular lens, phakic FDA UDI

Classification

Device Class
Class III EUDAMEDFDA UDI
Regulation Number
886.3600 FDA UDI
Market of Registration
Spain EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Posterior-chamber intraocular lens, phakic

EVO/EVO+VISIAN Implantable Collamer Lens by Staar Surgical Co. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Posterior-chamber intraocular lens, phakic.

Cleared under the same submission

P030016 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Staar Surgical Co.

Sources (2)

  • FDA UDI 860c62e7-9a1f-4429-868e-1a1f7ad85368 36 fields · synced Aug 1, 2026
  • EUDAMED 3bb8cb77-ff2a-4695-b154-f0be8205890d 61 fields · synced Aug 1, 2026