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Choyce Mark VIII Anterior Chamber Intraocular Lens

by Storz Ophthalmics, Inc.

PMA P800017

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P800017↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP800017 Date8 Aug 1985ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Choyce Mark VIII Anterior Chamber Interocular Lens
Generic Name
intraocular lens
PMA Number
FDA Product Code
HQL
Device Class
Class III
Regulation
21 CFR Part 886.3600
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S002

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Choyce Mark VIII Anterior Chamber Intraocular Lens is a foldable intraocular lens designed for implantation in the anterior chamber of the eye. It is intended to restore vision following cataract surgery or corneal trauma by replacing the natural lens with an artificial alternative, positioned in front of the iris and pupil.

This device is supplied as a single-use, sterile implant and requires surgical placement by an ophthalmologist. Authorized under FDA PMA (P800017), it adheres to regulatory standards for Class III ophthalmic devices (regulation number 886.3600). No MRI safety or reusable specifications are noted in the data. Storage and handling must comply with sterile surgical protocols.

Other devices from Storz Ophthalmics, Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Choyce Mark VIII Anterior Chamber Intraocular Lens used for, and how is it positioned in the eye?

    The Choyce Mark VIII is a **foldable intraocular lens** designed to replace the natural lens after cataract surgery or corneal trauma. It is implanted in the **anterior chamber**—positioned in front of the iris and pupil—to restore vision. Unlike posterior chamber lenses, this model sits closer to the cornea, making it suitable for specific cases where anterior placement is preferred.

  • Is the Choyce Mark VIII single-use or reusable, and what sterility guarantees are provided?

    The Choyce Mark VIII is explicitly labeled as a **single-use, sterile implant**. It must not be reused after one surgical procedure. Sterility is maintained through sterile packaging and handling protocols, adhering to standard surgical implant requirements for ophthalmic devices.

  • How is this device regulated in the U.S., and what does the PMA approval entail?

    The Choyce Mark VIII is authorized under an **FDA Premarket Approval (PMA)** with the number **P800017**, classifying it as a **Class III** device under regulation **886.3600**. PMA approval confirms the device meets rigorous safety and effectiveness standards for high-risk medical devices, including thorough clinical testing and review by the FDA.

  • Are there specific storage or handling instructions for the Choyce Mark VIII to maintain its integrity?

    Since it is a **sterile, single-use implant**, storage and handling must follow **aseptic surgical protocols** to prevent contamination. The device should be stored in its original packaging until immediately before use, per standard practices for intraocular lenses to ensure sterility and functionality.