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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: 19.0; Aspheric; Single Piece FDA UDIDiopter: 25.0; Aspheric; Single Piece FDA UDIDiopter: 17.5; Aspheric; Single Piece FDA UDIDiopter: 26.0; Aspheric; Single Piece FDA UDIDiopter: 29.5; Aspheric; Single Piece FDA UDIDiopter: 26.5; Aspheric; Single Piece FDA UDIDiopter: 11.0; Aspheric; Single Piece FDA UDIDiopter: 18.0; Aspheric; Single Piece FDA UDIDiopter: 21.5; Aspheric; Single Piece FDA UDI
- Model / Reference
- CC4204A FDA UDI
- Description
- Diopter: 19.0; Aspheric; Single Piece FDA UDIDiopter: 25.0; Aspheric; Single Piece FDA UDIDiopter: 17.5; Aspheric; Single Piece FDA UDIDiopter: 26.0; Aspheric; Single Piece FDA UDIDiopter: 29.5; Aspheric; Single Piece FDA UDIDiopter: 26.5; Aspheric; Single Piece FDA UDIDiopter: 11.0; Aspheric; Single Piece FDA UDIDiopter: 18.0; Aspheric; Single Piece FDA UDIDiopter: 21.5; Aspheric; Single Piece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841542102377 FDA UDI00841542102490 FDA UDI00841542102346 FDA UDI00841542102513 FDA UDI00841542102582 FDA UDI00841542102520 FDA UDI00841542102216 FDA UDI00841542102353 FDA UDI00841542102421 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Staar Surgical Co.
Sources (9)
- FDA UDI 07808f60-e25d-4672-92ab-38c97f7970ec 35 fields · synced Jun 6, 2026
- FDA UDI 7dbd06b9-2970-445a-b022-e634b82b3e40 35 fields · synced May 24, 2026
- FDA UDI e6e4747e-6d5b-4f92-983d-cd9f2c3618ad 35 fields · synced May 24, 2026
- FDA UDI e0124efc-ad88-4860-8c53-34d4f98a60d9 35 fields · synced May 25, 2026
- FDA UDI 05bb9eeb-c843-46b0-8527-faefb597d986 35 fields · synced May 25, 2026
- FDA UDI 4613dbb9-9571-4dbd-8bfc-b6098a1b6536 35 fields · synced May 25, 2026
- FDA UDI a2839708-65b1-494b-ac49-0ba33db4d47f 35 fields · synced May 26, 2026
- FDA UDI d67ff1b0-1a11-4cb6-b212-7bf00cf289e8 35 fields · synced May 26, 2026
- FDA UDI 3e5807ea-e8fb-4ca8-8d96-7e812d1f0224 35 fields · synced May 27, 2026