Identity
- Trade Name
- REFORM FDA UDI
- Generic Name
- Capsular tension ring FDA UDI
- Device Name
- REFORM CAPSULAR TENSION RING 12.3/10MM The ALCON ReFORM Capsular Tension Ring is a sterile, non-optical ocular implant, manufactured from a single piece of PMMA(POlymethylmethacrylate). FDA UDI
- Model / Reference
- 8065225703 FDA UDI
- Description
- REFORM CAPSULAR TENSION RING 12.3/10MM The ALCON ReFORM Capsular Tension Ring is a sterile, non-optical ocular implant, manufactured from a single piece of PMMA(POlymethylmethacrylate). FDA UDI
Identifiers
- Catalog Number
- ACTR10 FDA UDI
- Primary DI / UDI-DI
- 00380652257039 FDA UDI
- FDA Product Code
- MRJ FDA UDI
- GMDN Term
- Capsular tension ring 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 12.3 Millimeter FDA UDI
Category: Capsular tension ring
Reform by Alcon Laboratories, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Capsular tension ring.
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- EYEJET® CTR — Morcher GmbH · Class III
- EYEJET® CTR — Morcher GmbH · Class III
- Capsular Tension Ring — Ophtec B.V. · Class III
- EYEJET® CTR — Morcher GmbH · Class III
- EYEJET® CTR — Morcher GmbH · Class III
- EYEJET® CTR — Morcher GmbH · Class III
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
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI f00adc6e-f073-475a-8019-f7a982a0f33e 36 fields · synced May 31, 2026