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Rigid Gas Permeable Contact Lens Solution

by Polymer Technology Div. Wilmington Partners, L.P.

510(k) K983836

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983836 Date11 Feb 1999ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0553-2010 FDA Unclassified (pre-2012) initiated 30 Oct 2009

    The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors.

    • Terminated Z-1735-2009 FDA Unclassified (pre-2012) initiated 30 Jun 2009 on shared 510(k) K983836

    The product failed to meet one of the shelf life specifications at the end of the expiry period.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MRC
Device Class
Class II
Regulation
21 CFR Part 886.5918
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a Rigid Gas Permeable Contact Lens Solution, classified under Products, Contact Lens Care, Rigid Gas Permeable by the FDA. It is a sterile, buffered chemical solution designed to maintain and preserve the integrity of rigid gas permeable (RGP) contact lenses. The solution contains chlorhexidine gluconate and edetate disodium as preservatives, ensuring both disinfection and wetting properties for lens care.

Intended for patient use, this solution is supplied in a sterile, single-use or multi-use format (as per labeling) and is used to clean, disinfect, and store RGP lenses after initial cleaning and rinsing. It adheres to FDA regulation 886.5918 and holds a 510(k) clearance (K983836) under the Medical Specialty Description: Ophthalmic. The product is classified as a Class II device and is regulated under the Product Code: MRC for contact lens care solutions.

Other devices from Polymer Technology Div. Wilmington Partners, L.P.

Questions

AI-generated answers, 1 Oct 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 this solution designed to do for rigid gas permeable (RGP) lenses?

    This solution is formulated to maintain and preserve the integrity of RGP contact lenses by providing disinfection, cleaning, and wetting properties. It contains chlorhexidine gluconate and edetate disodium, which work together to ensure lenses remain hygienic and properly hydrated during storage. This prevents protein buildup, microbial contamination, and lens damage, extending their lifespan and ensuring safe wear.

  • Is this solution sterile and how is it supplied?

    Yes, this solution is sterile as manufactured. It is available in both single-use and multi-use formats, depending on the specific packaging. The labeling clearly indicates whether the solution is intended for one-time use or repeated use over multiple days. Always follow the manufacturer’s instructions to avoid cross-contamination or improper storage.

  • What preservatives are included, and why are they important?

    The solution contains chlorhexidine gluconate (an antimicrobial agent) and edetate disodium (a chelating agent). Chlorhexidine gluconate kills or inhibits bacteria and fungi, reducing the risk of lens-related infections. Edetate disodium helps remove mineral deposits and proteins from the lens surface, maintaining clarity and comfort during wear. Together, they ensure both disinfection and proper lens hydration.

  • Can this solution be reused, or is it intended for single-use only?

    The solution is available in both single-use and multi-use formats, as indicated on the packaging. Single-use solutions are designed for one-time application to minimize contamination risk, while multi-use solutions are intended for repeated use over several days, provided proper handling and storage protocols are followed. Always check the label or instructions for the specific format you are using.

  • How should this solution be stored to maintain its effectiveness?

    Store the solution in a cool, dry place away from direct sunlight and extreme temperatures. Once opened, if it is a multi-use solution, replace it after the recommended usage period (typically 28 days) to prevent microbial growth. Single-use solutions should be discarded immediately after opening. Contaminated or expired solutions can compromise lens hygiene and eye safety.