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Ophtec Capsular Tension Ring (276 +3 more) - Stabileyes Models STBL2US

by Ophtec BV

PMA P030023

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P030023↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP030023 Date27 Apr 2004ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Ring, endocapsular
PMA Number
FDA Product Code
MRJ
Models / Variants
Stabileyes Models STBL2US
Device Class
Class III
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved

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 device is an endocapsular ring indicated for the stabilization of weakened, broken or missing zonules suspected or observed during cataract extraction using phacoemulsification and continuous curvilinear capsulorhexis techniques in adults. It is designed to support the capsular bag and maintain lens position following implantation.

Supplied as a sterile, single-use implant. Manufactured by Ophtec BV in Groningen, Netherlands. Authorized under FDA PMA P030023. Distributed by Advanced Medical Optics as the Stabileyes capsular tension ring (Models STBL2US and STBL13US).

Other devices from Ophtec BV

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 primary intended use of the OPHTEC Capsular Tension Ring?

    The device is indicated for the stabilization of weakened, broken or missing zonules that are suspected or observed during cataract extraction using phacoemulsification and continuous curvilinear capsulorhexis techniques in adults.

  • How are the OPHTEC Models 275 and 276 related to the Stabileyes models STBL2US and STBL13US?

    The OPHTEC Capsular Tension Ring Models 275 (10/12 mm) and 276 (11/13 mm) are also known as the Stabileyes Capsular Tension Ring and are distributed by Advanced Medical Optics under the model designations STBL2US and STBL13US.

  • Is the OPHTEC Capsular Tension Ring reusable or single-use?

    The device is supplied as a sterile, single-use implant intended for one-time use during cataract surgery.