BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOT AVAILABLE

    MDR report key: 4213385 · Received October 24, 2014

    Report

    Report Number
    9611165-2014-00073
    Event Type
    Other
    Date Received
    October 24, 2014
    Report Date
    October 7, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P06011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THIS EVENT WAS BROUGHT TO RAYNER'S NOTIFICATION BY THE HEALTHCARE PROFESSIONAL AS HE HAD UNDERGONE A PEER REVIEWED AUDIT AND WAS ADVISED TO REPORT THE FOUR CASES OF ACCS THAT HAD DEVELOPED POST IMPLANTATION WITH RAYNER LENSES (PLEASE REFER ALSO TO MDRS 9611165-2014-00073, 00074 AND 00075). THE HEALTHCARE PROFESSIONAL NOTIFIED THE RAYNER SALES SPECIALIST THAT HE BELIEVED THAT THE PHACO MACHINE UTILISED MAY BE SOMEWHAT IMPLICATED. THE HEALTHCARE PROFESSIONAL EXPLAINED THAT AFTER LENS IMPLANTATION, HE HAD FOUND THAT NUCLEAR MATERIAL WAS STILL PRESENT IN THE EYE AND HADN'T BEEN BROKEN DOWN BY THE PHACO MACHINE. MATERIAL LEFT WITHIN THE EYE COULD POTENTIALLY TRIGGER LENSE EPITHELIAL GROWTH THEREFORE CONTRIBUTING TO ACCS. ACCS HAS BEEN ASSOCIATED WITH MULTIPLE ENTITIES. MOST COMMON IS A SMALL DIAMETER CAPSULORHEXIS. ZONULAR WEAKNESS, CHRONIC INTRAOCULAR INFLAMMATION, UVEITIS, PSEUDOEXFOLIATION SYNDROME, RETINITIS PIGMENTOSA, ADVANCED AGE, DIABETES MELLITUS, BEHCET'S SYNDROME, MYOTONIC MUSCULAR DYSTROPHY, AND HIGH MYOPIA, ARE KNOWN RISK FACTORS. RAYNER IS LIAISING WITH THE HEALTHCARE PROFESSIONAL TO OBTAIN ADDITIONAL INFORMATION TO AID US IN DETERMINING THE ROOT CAUSE OF ACCS.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A HEALTHCARE PROFESSIONAL OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNOR IOL. THE HEALTHCARE PROFESSIONAL REPORTS THAT THE PATIENT IS SUFFERING WITH ANTERIOR CAPSULAR CONTRACTION SYNDROME (ACCS) POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678908 NOT AVAILABLE HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1