Identity
- Trade Name
- MDR FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- POSTERIOR CHAMBER INTRAOCULAR LENS FDA UDI
- Model / Reference
- P260-2UV-07.0 FDA UDI
- Description
- POSTERIOR CHAMBER INTRAOCULAR LENS FDA UDI
Identifiers
- Primary DI / UDI-DI
- M454P2602UVP0701 FDA UDI
- PMA Number
- P880072 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Posterior-chamber intraocular lens, pseudophakic
The MDR intraocular lens (IOL) is a permanent implantable device designed to replace the natural lens in the posterior chamber of the eye. Made from synthetic material, it provides clear vision and maintains optical clarity for years. The device is sterilized via UV light and does not require refrigeration or cryotherapy.
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
- 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
- TECNIS IOL — Johnson & Johnson Surgical Vision, Inc. · Class III
Cleared under the same submission
P880072 also covers:
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACURUS — EYEKON MEDICAL, INC.
- ACURUS — EYEKON MEDICAL, INC.
- ACURUS — EYEKON MEDICAL, INC.
- ACURUS — EYEKON MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Eyekon Medical, Inc.
Sources (1)
- FDA UDI d216d013-9459-4c59-b966-bcd8501126f8 34 fields · synced Jul 18, 2026