BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERFLEX

    MDR report key: 3122664 · Received May 17, 2013

    Report

    Report Number
    9611165-2013-00034
    Event Type
    Other
    Date Received
    May 17, 2013
    Date of Event
    August 18, 2010
    Report Date
    February 5, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN ALLOCATED TO THIS EVENT BY RAYNER INTRAOCULAR LENSES LIMITED. REMEDIAL, CORRECTIVE AND PREVENTIVE ACTION WAS TAKEN BY THE HEALTHCARE FACILITY. THE SUPERFLEX 620H IOL WAS EXPLANTED ON (B)(6) 2013 AND EXCHANGED FOR AN ANTERIOR CHAMBER IOL. THE DEVICE ANALYSIS CONCLUDED THAT "SEM AND EDX SPECTROSCOPY REVEALED CRYSTALLIN DEPOSITS DIRECTLY BELOW THE SURFACE OF THE IOL. THE CRYSTALS WERE MADE OF CAPO4." RAYNER WERE ADVISED THAT THE PT HAD AN OCULAR HISTORY OF PROLIFERATIVE DIABETIC RETINOPATHY. RAYNER HAS BEEN ADVISED BY A MEDICAL PROFESSIONAL THAT DIABETIC PTS ARE MORE PREDISPOSED TO A BREAKDOWN OF THE BLOOD-AQUEOUS BARRIER. THE SUPERFLEX 620H IOL IFU CONTRAINDICATES THE USE OF THIS IOL IN PTS WITH ACTIVE OCULAR DISEASES (CHRONIC SEVERE UVEITIS, PROLIFERATIVE DIABETIC RETINOPATHY, CHRONIC GLAUCOMA NOT RESPONSIVE TO MEDICATION). OUR REVIEW OF PRODUCTION RECORDS FOR THE SUPERFLEX 620H IOL BATCH 094E57137 SHOWED THAT ALL MFG AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL LENSES RELEASED FOR DISTRIBUTION FROM THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE W/O DEFECTS. A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE SUPERFLEX 620H IOL CONFIRMS THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN REC'D AGAINST THE SUPERFLEX 620H IOL BATCH 094E57137.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED REC'D NOTIFICATION FROM (B)(6) HOSPITAL ((B)(6)) OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A SUPERFLEX 620H INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY INDICATES THAT OPACIFICATION WAS OBSERVED ON THE ANTERIOR AND POSTERIOR SURFACE OF THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219126 SUPERFLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 620H 094E57137

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention