Identity
- Trade Name
- Clareon EUDAMEDFDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- Clareon Aspheric IOL SY60WF EUDAMEDSTERILE UV and Blue Light Filtering Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens FDA UDI
- Model / Reference
- SY60WF.180 EUDAMEDSY60WF FDA UDI
- Description
- STERILE UV and Blue Light Filtering Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380652251440 EUDAMEDFDA UDI
- Basic UDI-DI
- 038065GMN000135H3 EUDAMED
- FDA Product Code
- HQL FDA UDI
- EMDN Code
- P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC EUDAMED
- GMDN Term
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Regulation Number
- 886.3600 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
Yes
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Posterior-chamber intraocular lens, pseudophakic
Clareon by Alcon Laboratories, Inc. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (2)
- FDA UDI 3449bfc4-0115-4dcb-905b-18df854ceb39 33 fields · synced Oct 8, 2026
- EUDAMED 79c8ce81-f3b3-49b1-b325-4245f0824543 61 fields · synced Oct 8, 2026