Hydroview Composite Hydrogel Foldable UV-Absorbing Posterior Chamber Intraocular Lens
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS FDA PMA
- Generic Name
- intraocular lens FDA PMA
Identifiers
- PMA Number
- P990014 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
The Hydroview Composite Hydrogel Foldable UV-Absorbing Posterior Chamber Intraocular Lens is an intraocular lens indicated for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed by extracapsular extraction methods. The lens is intended for placement in the capsular bag.
This device is supplied sterile and is intended for single-use implantation in a surgical setting. It is a Class III medical device authorized under FDA PMA P990014, with product code HQL and regulation number 886.3600, manufactured by Bausch & Lomb, Inc. in Irvine, CA.
Frequently asked questions
What is the intended use of the Hydroview Composite Hydrogel Foldable UV-Absorbing Posterior Chamber Intraocular Lens?
The lens is indicated for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed by extracapsular extraction methods, with placement intended in the capsular bag.
Is the Hydroview Composite Hydrogel Foldable UV-Absorbing IOL reusable or single-use?
The device is supplied sterile and is intended for single-use implantation, as indicated by its classification as an implantable intraocular lens requiring sterile delivery and surgical implantation.
What regulatory authorization does the Hydroview Composite Hydrogel Foldable UV-Absorbing IOL have?
The device is authorized under FDA PMA with number P990014, as stated in the AUTHORIZATIONS field and confirmed by the PMA_NUMBER specification.
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 | P990014 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P990014 24 fields · synced Sep 18, 2026