BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERFLEX ASPHERIC

    MDR report key: 3799540 · Received April 23, 2014

    Report

    Report Number
    9611165-2014-00054
    Event Type
    Injury
    Date Received
    April 23, 2014
    Report Date
    April 14, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER HAS ALLOCATED THE REFERENCE (B)(4) TO THIS CASE. SLIT LAMP PHOTOGRAPHS WERE PROVIDED TO RAYNER FOR REVIEW BY THE DISTRIBUTOR IN (B)(6). THE SLIT LAMP PHOTOGRAPHS RECEIVED WERE SENT TO A CLINICAL CONSULTANT FOR REVIEW. THE FEEDBACK RECEIVED FROM THE CLINICAL CONSULTANT IS AS FOLLOWS: "THE PICTURES CERTAINLY SHOW AT LEAST COATING ON THE SURFACE OF THE IOL. WHETHER THE SUBSTANCE OF THE IOL IS ALSO OPACIFIED OR NOT IS DIFFICULT TO TELL FROM THE PICTURES SUPPLIED. THE IOL IS DISLOCATED AND THERE IS PC RUPTURE. IOL SURFACE DEPOSITS AND SUBSTANCE OPACIFICATION OCCURS IN 'SICK EYES'. THIS PARTICULAR EYE HAS A VERY LONG HISTORY OF MULTIPLE PROBLEMS, MULTIPLE SURGERIES AND INTERVENTIONS AND THE DEPOSITS ON THE IOL ARE RELATED TO THESE. IN MY OPINION, FOLLOWING FACTORS MAY HAVE CONTRIBUTED TO A CHRONIC INFLAMED EYE LEADING TO SURFACE DEPOSITS ON IOL. DIABETES, PROLIFERATIVE DIABETIC RETINOPATHY, VITREOUS HAEMORRHAGE, INTRA-VITREAL INJECTIONS OF AVASTIN, POSTERIOR CAPSULE RUPTURE WHICH MUST HAVE HAPPENED DURING COMPLICATED SURGERY. EXPOSURE OF IOL TO VITREOUS ETC. WHEN IOL IS EXPOSED TO CHRONIC INFLAMMATION, VARIOUS SURGERIES, INJECTION OF PHARMACEUTICAL AGENTS SUCH AS AVASTIN, THE RISK OF SURFACE DEPOSITS INCREASES SIGNIFICANTLY. THIS CAN HAPPEN WITH ANY IOL". THE IOL HAS BEEN EXPLANTED AND RETURNED TO RAYNER.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE DISTRIBUTOR IN (B)(6) OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A SUPERFLEX ASPHERIC 920H INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED STATES THAT THE HEALTHCARE PROFESSIONAL OBSERVED THE DEVELOPMENT OF OPACIFICATION IN THE POST-OPERATIVE PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245369 SUPERFLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 920H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SIX TIMES IN THE PERIOD 2010 - 2013.| AVASTIN HAS BEEN PRESCRIBED TO THE PATIENT