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Visian ICL (Implantable Collamer Lens)

FDA UDI

Class III (US FDA UDI)

by Staar Surgical Co.

Identity

Trade Name
Visian ICL (Implantable Collamer Lens) FDA UDI
Generic Name
Posterior-chamber intraocular lens, phakic FDA UDI
Device Name
Diopter: -7.0; Overall Diameter (Length): 12.1 mm FDA UDI
Diopter: -3.0; Overall Diameter (Length): 12.1 mm FDA UDI
Diopter: -10.0; Overall Diameter (Length): 12.1 mm FDA UDI
Diopter: -14.0; Overall Diameter (Length): 12.1 mm FDA UDI
Model / Reference
MICL 12.1 FDA UDI
Description
Diopter: -7.0; Overall Diameter (Length): 12.1 mm FDA UDI
Diopter: -3.0; Overall Diameter (Length): 12.1 mm FDA UDI
Diopter: -10.0; Overall Diameter (Length): 12.1 mm FDA UDI
Diopter: -14.0; Overall Diameter (Length): 12.1 mm FDA UDI

Identifiers

Primary DI / UDI-DI
00841542102698 FDA UDI
00841542102612 FDA UDI
00841542102759 FDA UDI
00841542102834 FDA UDI
PMA Number
P030016 FDA UDI
FDA Product Code
MTA FDA UDI
GMDN Term
Posterior-chamber intraocular lens, phakic FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI

Category: Posterior-chamber intraocular lens, phakic

Visian ICL (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 (4)

  • FDA UDI 6146b43f-df90-4e5a-b93c-99ea1fb5f702 35 fields · synced Jun 1, 2026
  • FDA UDI d5fc3ce1-a519-44b1-9cf7-47a8840f09f4 35 fields · synced May 25, 2026
  • FDA UDI a317ae47-34bc-4514-946d-9c764c4e1398 35 fields · synced May 25, 2026
  • FDA UDI 964b1f26-bbb8-492a-af62-5ac0d54868e3 35 fields · synced May 27, 2026