BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERFLEX

    MDR report key: 2620972 · Received June 6, 2012

    Report

    Report Number
    9611165-2012-00026
    Event Type
    Injury
    Date Received
    June 6, 2012
    Date of Event
    October 1, 2011
    Report Date
    April 4, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS EVENT BY RAYNER INTRAOCULAR LENSES LIMITED. THE DEVICE ANALYSIS PERFORMED BY AN INDEPENDENT THIRD PARTY TESTING FACILITY CONFIRMED THAT THERE WERE CRYSTALLINE DEPOSITS DIRECTLY BELOW THE INTRAOCULAR LENS SURFACE HOWEVER, COULD NOT ASCERTAIN THE ROOT CAUSE OF THE DEVELOPMENT OF OPACIFICATION. THE PHYSICIAN COMMENTED IN HIS CORRESPONDENCE WITH RAYNER INTRAOCULAR LENSES LIMITED THAT "SURGERY WAS NOT STRAIGHT FORWARD (IN TERMS OF NEEDING A SECOND INJECTION OF AIR INTO THE ANTERIOR CHAMBER OR OF THE SURGERY BEING A REPEAT CORNEAL ENDOTHELIAL GRAFT, ETC). MY HUNCH IS THAT BREAKDOWN OF THE NORMAL BLOOD-AQUEOUS BARRIER HAS SOMETHING TO DO WITH IT." OUR REVIEW OF PRODUCTION RECORDS FOR THE SUPERFLEX 620H BATCH 118E85260 CONFIRMS THAT ALL MANUFACTURING AND QUALITY CHECKS WERE SATISFACTORY. ALL LENSES RELEASED FROM THIS BATCH WERE WITHIN SPECIFICATION. COMPLAINTS SINCE (B)(4) 2008, THE MONTH OF MANUFACTURE, WERE REVIEWED AND WE CAN CONFIRM THAT NO COMPLAINTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE SUPERFLEX 620H BATCH 118E85260. THERE IS NO INDICATION FROM THE RESULTS OF THE ANALYSIS OR OF OUR PRODUCTION RECORD REVIEW THAT THIS EVENT HAS OCCURRED AS A RESULT OF A DEVICE DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED WERE NOTIFIED BY (B)(6) HOSPITAL (B)(6) ABOUT A SUSPECTED OPACIFICATION CASE WITH A PT WHO RECEIVED A RAYNER INTRAOCULAR LENS FOLLOWING CORNEAL ENDOTHELIAL GRAFT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERFLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 620H 118E85260

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention