Clareon CCWET4
by Alcon Laboratories, Inc. 41 variants
Ref CCWET4.110
Active
Valid until
No date given
FDA recalls
Not checked
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number038065GMN000245HB 00380652486125 | Date3 Aug 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00380652486125 | Date9 Dec 2021 | StatusListed |
Certificates
- G70 020895 0414 Withdrawn
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 11 Jun 2026
- Expires
- 20 Jan 2030
- Reason
- Transferred to other nb
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Clareon Vivity EUDAMEDClareon GUDID
- Generic name
- Posterior-chamber intraocular lens, pseudophakic
- Device name
- Clareon Vivity Toric Extended Vision UV Absorbing IOL
- Model / reference
- CCWET4.110 EUDAMEDCCWET4 GUDID
- Primary DI / UDI-DI
- 00380652486125
- Basic UDI-DI
- 038065GMN000245HB
- FDA product code
- HQL
- EMDN code
- P030102100301 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC
- GMDN term
- Posterior-chamber intraocular lens, pseudophakic
- Device class
- Class IIb EUDAMEDClass III GUDID
- Regulation number
- 886.3600
- EU registration type
- Standard device
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | CCWET4.110 | CCWET4 |
| Device class | Class IIb | Class III |
Overview
AI-generated summary, 11 Nov 2026
Clareon CCWET4 is a posterior-chamber intraocular lens, pseudophakic that functions as an optical implant to replace the eye's natural crystalline lens. The device is designated with model number CCWET4 under the Clareon brand name. It is supplied sterile and is intended for single use.
The device is categorized as FDA Class III under regulation number 886.3600 with product code HQL. It was associated with EU MDR certificate G70 020895 0414, which was withdrawn on 2026-08-03. The records also include an EU MDR registration.
Other devices from Alcon Laboratories, Inc.
Questions
AI-generated answers, 11 Nov 2026
What is the Clareon CCWET4?
It is recorded under the GMDN device type "Posterior-chamber intraocular lens, pseudophakic", which GMDN defines as "An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens ...". FDA lists it under the product name "Intraocular Lens". It is recorded as FDA Class III.
What is the regulatory status of the Clareon CCWET4?
The registry records EU MDR certification G70 020895 0414 dated 2026-06-11, status withdrawn, withdrawn on 2026-08-03 and an EU MDR registration.
What are the product code and regulation of the Clareon CCWET4?
FDA records the Clareon CCWET4 under product code HQL and regulation number 886.3600.
Who makes the Clareon CCWET4?
Alcon Laboratories, Inc. is the manufacturer on record for the Clareon CCWET4.
Properties
Other properties (20)
- Sterilise before use: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Sutures: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No
- Prescription use: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Lot / batch number: No
- Expiration date: No