Identity
- Trade Name
- Visian ICL (Implantable Collamer Lens) FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, phakic FDA UDI
- Device Name
- Diopter: -6.5; Overall Diameter (Length): 13.2 mm FDA UDI
- Model / Reference
- MICL 13.2 FDA UDI
- Description
- Diopter: -6.5; Overall Diameter (Length): 13.2 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841542103220 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.
- 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 33fcb566-5b14-4b8e-aea3-1ca7ec41f8c3 35 fields · synced Jun 1, 2026