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Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- Diopter: 15.0; Aspheric; Single Piece FDA UDI
- Model / Reference
- CC4204A FDA UDI
- Description
- Diopter: 15.0; Aspheric; Single Piece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841542102292 FDA UDI
- PMA Number
- P990013 FDA UDI
- FDA Product Code
- HQL FDA UDI
- GMDN Term
- Posterior-chamber intraocular lens, pseudophakic 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
No
FDA UDI
Category: Posterior-chamber intraocular lens, pseudophakic
Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens by Staar Surgical Co. — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Posterior-chamber intraocular lens, pseudophakic.
- TECNIS IOL — Johnson & Johnson Surgical Vision, Inc. · Class III
- Clareon — Alcon Laboratories, Inc. · Class III
- SMARTLOAD — Johnson & Johnson Surgical Vision, Inc. · Class III
- ISOTECHNICS — EYEKON MEDICAL, INC. · Class III
- TECNIS IOL — Johnson & Johnson Surgical Vision, Inc. · Class III
- enVista Aspire™ Toric IOL — Bausch & Lomb Incorporated · Class III
- TECNIS SIMPLICITY — Johnson & Johnson Surgical Vision, Inc. · Class III
- enVista® Toric IOL — Bausch & Lomb Incorporated · Class III
Cleared under the same submission
P990013 also covers:
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens — Staar Surgical Co.
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular 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 70ebe730-0e81-4438-afab-5254e4a33b64 35 fields · synced May 31, 2026