EVO/EVO+VISIAN Implantable Collamer Lens
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- EVO+ Visian ICL EUDAMEDEVO/EVO+VISIAN Implantable Collamer Lens FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, phakic FDA UDI
- Device Name
- Implantable Collamer Lens EUDAMEDVICM5 - Diopter: -14.0; Overall Diameter (Length): 12.6 FDA UDI
- Model / Reference
- VICM5 12.6 EUDAMEDVICM5 12.6 (-14.0) FDA UDI
- Description
- VICM5 - Diopter: -14.0; Overall Diameter (Length): 12.6 FDA UDI
Identifiers
- Catalog Number
- VICM5 12.6 FDA UDI
- Primary DI / UDI-DI
- 00840311300686 EUDAMEDFDA UDI
- Basic UDI-DI
- 764013516ICLGV EUDAMED
- PMA Number
- P030016 FDA UDI
- FDA Product Code
- MTA FDA UDI
- EMDN Code
- P030101030199 IOLs, PHAKIC, MONOFOCAL, SPHERICAL - OTHER EUDAMED
- GMDN Term
- Posterior-chamber intraocular lens, phakic FDA UDI
Classification
- Device Class
- Class III EUDAMEDFDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
Yes
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
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.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co. · Class III
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co. · Class III
- Visian Toric ICL (Implantable Collamer Lens for Myopia) — Staar Surgical Co. · Class III
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co. · Class III
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co. · Class III
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co. · Class III
- Visian Toric ICL (Implantable Collamer Lens for Myopia) — Staar Surgical Co. · Class III
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co. · Class III
Cleared under the same submission
P030016 also covers:
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
- EVO/EVO+VISIAN Implantable Collamer Lens — Staar Surgical Co.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Staar Surgical Co.
Sources (2)
- FDA UDI 761df85f-65b7-4f85-bf80-1a9f0ff785cb 36 fields · synced Sep 17, 2026
- EUDAMED 227bb366-0362-4c7b-8eba-be99d66d7640 61 fields · synced Sep 17, 2026