Identity
- Trade Name
- SENSAR MONOFOCAL 3-PIECE IOL EUDAMEDSENSAR IOL FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- SENSAR SPHERICAL MONOFOCAL 3-PIECE IOL EUDAMEDACRY 13.5mm 6 OPT MOD C PMMA OPTIEDGE FDA UDI
- Model / Reference
- AR40MN0085 EUDAMEDAR40M FDA UDI
- Description
- ACRY 13.5mm 6 OPT MOD C PMMA OPTIEDGE FDA UDI
Identifiers
- Catalog Number
- AR40MN0085 FDA UDI
- Primary DI / UDI-DI
- 05050474514300 EUDAMEDFDA UDI
- Basic UDI-DI
- 5050474a000409C EUDAMED
- FDA Product Code
- HQL FDA UDI
- EMDN Code
- P030102090101 IOLs, APHAKIC, MONOFOCAL, SPHERICAL, 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
- Ireland 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
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
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
Dimensions & Sizes
- Size
- Outer Diameter — 13.5 Millimeter FDA UDI
Category: Posterior-chamber intraocular lens, pseudophakic
Sensar Iol by Johnson & Johnson Surgical Vision, 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
- Johnson & Johnson Surgical Vision, Inc.
Sources (2)
- FDA UDI fdc83383-f99c-4fe3-af43-3406e0ac6b7d 37 fields · synced Oct 7, 2026
- EUDAMED 30cb2d11-3171-488e-aaaf-e35c1bb22d99 61 fields · synced Oct 7, 2026