Identity
- Trade Name
- MODEL 91-50 IOL FDA PMA
- Generic Name
- intraocular lens FDA PMA
Identifiers
- PMA Number
- P820044 FDA PMA
- FDA Product Code
- HQL FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.3600 FDA PMA
- Regulation Number
- 886.3600 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APWD FDA PMA
Model 91-50 IOL is an intraocular lens designed for implantation in the eye to replace the natural lens following cataract extraction. It is classified as a Class III medical device under FDA regulation 886.3600 and is intended for use in ophthalmic surgical procedures.
This device is supplied as a sterile, single-use implant and is manufactured by Bausch & Lomb, Inc. in Rochester, NY. It received FDA PMA approval on December 27, 1985, under PMA number P820044, and is identified by product code HQL. The lens is intended for use in clinical settings by qualified ophthalmic surgeons.
Frequently asked questions
What is the Model 91-50 IOL used for?
The Model 91-50 IOL is an intraocular lens used to replace the eye's natural lens after cataract removal. It is implanted during ophthalmic surgery to restore vision and is classified as a Class III device under FDA regulation 886.3600.
Who manufactures the Model 91-50 IOL and where is it made?
The Model 91-50 IOL is manufactured by Bausch & Lomb, Inc., located at 1400 N. Goodman St., Rochester, NY 14609. This information is drawn directly from the device's official specifications and registration data.
What regulatory approval does the Model 91-50 IOL have?
The Model 91-50 IOL received FDA Premarket Approval (PMA) under number P820044, with the decision date of December 27, 1985. It is classified as a Class III device and is identified in the FDA's OpenFDA database under product code HQL.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P820044 | Class III | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P820044 24 fields · synced Sep 18, 2026