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Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens Model C11UB

FDA PMA

Class III (US FDA PMA)

PMA P910058

by Bausch & Lomb, Inc.

Identity

Trade Name
CHIROFLEX MODELS 32 C10XX SILICONE POSTERIOR IOL FDA PMA
Generic Name
intraocular lens FDA PMA

Identifiers

PMA Number
P910058 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

This device is an ultraviolet-absorbing silicone posterior chamber intraocular lens, designed to replace the natural lens in cataract surgery or following lens dislocation. It is classified as an intraocular lens and is intended for implantation within the eye’s posterior chamber to restore visual function by focusing light onto the retina.

The Model C11UB is supplied sterile and intended for single-use. It is regulated under FDA Premarket Approval (PMA) and falls under product code HQL. The lens is manufactured by Bausch & Lomb, Inc., and must be handled in accordance with sterile surgical protocols. No MRI safety information or reusable specifications are indicated in the provided data.

Frequently asked questions

What is the primary purpose of the Model C11UB intraocular lens, and in which types of eye surgeries is it typically used?

The Model C11UB is an ultraviolet-absorbing silicone posterior chamber intraocular lens designed to replace the natural lens in cataract surgery or following lens dislocation. It is implanted within the eye’s posterior chamber to restore visual function by focusing light onto the retina, effectively correcting vision impaired by lens opacity or dislocation.

Is the Model C11UB lens intended for reuse, or is it meant to be used only once per patient?

The Model C11UB is explicitly intended for single-use only. It is supplied sterile and must adhere to sterile surgical protocols, meaning it should not be reused on multiple patients to maintain safety and sterility standards.

How is the regulatory approval process for this device structured, and what does the product code HQL indicate?

The Model C11UB is regulated under the FDA’s Premarket Approval (PMA) pathway, indicated by the PMA number (P910058). The product code **HQL** categorizes it as an intraocular lens under FDA classification, reflecting its use in ophthalmic procedures. This route ensures rigorous evaluation before market authorization.

What special handling or storage considerations apply to the Model C11UB lens?

Since the Model C11UB is sterile and single-use, it must be handled using strict sterile surgical protocols to prevent contamination. Storage should follow manufacturer guidelines to preserve sterility, typically in a sealed, sterile packaging until immediate preoperative use.

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

United States Active

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Manufacturer

Manufacturer
Bausch & Lomb, Inc.

Sources (1)

  • FDA PMA P910058 24 fields · synced Sep 18, 2026