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EVO/EVO+VISIAN Implantable Collamer Lens

FDA UDI

Class III (US FDA UDI)

by Staar Surgical Co.

Identity

Trade Name
EVO/EVO+VISIAN Implantable Collamer Lens FDA UDI
Generic Name
Posterior-chamber intraocular lens, phakic FDA UDI
Device Name
VTICM5 - Diopter: -9.5; Cylinder 2.5; Overall Diameter (Length): 12.1 FDA UDI
Model / Reference
VTICM5 12.1 (-9.5/2.5) FDA UDI
Description
VTICM5 - Diopter: -9.5; Cylinder 2.5; Overall Diameter (Length): 12.1 FDA UDI

Identifiers

Catalog Number
VTICM5 12.1 FDA UDI
Primary DI / UDI-DI
00840311305292 FDA UDI
PMA Number
P030016 FDA UDI
FDA Product Code
QCB FDA UDI
GMDN Term
Posterior-chamber intraocular lens, phakic FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
886.3600 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Posterior-chamber intraocular lens, phakic.

Cleared under the same submission

P030016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Staar Surgical Co.

Sources (1)

  • FDA UDI e7f5fc7d-3201-48d9-b34c-f979ec2ac231 36 fields · synced May 30, 2026