Identity
- Trade Name
- EVO/EVO+VISIAN Implantable Collamer Lens FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, phakic FDA UDI
- Device Name
- VTICM5 - Diopter: -6.5; Cylinder 3.0; Overall Diameter (Length): 13.2 FDA UDI
- Model / Reference
- VTICM5 13.2 (-6.5/3.0) FDA UDI
- Description
- VTICM5 - Diopter: -6.5; Cylinder 3.0; Overall Diameter (Length): 13.2 FDA UDI
Identifiers
- Catalog Number
- VTICM5 13.2 FDA UDI
- Primary DI / UDI-DI
- 00841542116121 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
MR Safe FDA UDI
Category: Posterior-chamber intraocular lens, phakic
The EVO/EVO+ VISIAN implantable collamer lens is a posterior-chamber intraocular lens (IOL) designed for post-surgical vision correction in patients with myopia or hyperopia. This device is made of synthetic polymer and is implanted permanently in the eye to provide refractive correction.
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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Staar Surgical Co.
Sources (1)
- FDA UDI 7886ddaa-d85a-4c1e-9774-b565913f0ea8 36 fields · synced Jul 30, 2026