BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERFLEX ASPHERIC

    MDR report key: 1736274 · Received June 23, 2010

    Report

    Report Number
    9611165-2010-00007
    Event Type
    Injury
    Date Received
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE PARENT LENS AND INJECTOR BATCH PROCESS RECORDS CONFIRM ROUTINE MANUFACTURE AND STERILIZATION. THERE IS NOTHING IN THE PRODUCTION RECORDS TO SUGGEST THAT EITHER THE LENS OR THE INJECTOR WERE DEFECTIVE. REVIEW OF COMPLAINT FILES INDICATE NO OTHER COMPLAINTS HAVE BEEN LODGED AGAINST THIS LOT NUMBER. THE OPERATING SURGEON PROVIDED PICTURES OF THE IMPLANTED LENS TO RAYNER, WHICH HAVE BEEN SENT TO THE RAYNER OPHTHALMIC SURGERY CONSULTANT FOR REVIEW AND OPINION. ANALYSIS IS ONGOING. THE SURGEON HAS STATED THAT HE INTENDS TO EXPLANT THE DEVICE DURING (B) (6) 2010. RAYNER IS ASSISTING THE SURGEON IN CONTACTING AN INDEPENDENT TEST LABORATORY WHICH CAN EXAMINE AND TEST THE LENS AFTER EXPLANTATION. THE RESULTS OF TESTING WILL BE REVIEWED, IF MADE AVAILABLE TO RAYNER BY THE SURGEON. THIS MODEL, 920H, IS NOT AVAILABLE IN THE USA. (B) (4)

    Description of Event or Problem · 1

    THE SURGEON REPORTED A DISTORTION ON THE ANTERIOR SURFACE OF THE LENS. THE PATIENT HAS PROLIFERATIVE DIABETIC RETINOPATHY AND VITREOUS HEMORRHAGE. A PHACO VITRECTOMY WAS PERFORMED WITHOUT COMPLICATIONS. HEMORRHAGE RECURRED POSTOPERATIVELY AND INTRAOCULAR AVASTIN WAS INJECTED AFTER ONE MONTH, SOLVING THE PROBLEM. THE PATIENT REPORTED POOR VISION A COUPLE OF MONTHS AGO AND THE SURGEON OBSERVED THE SHRINKAGE ON THE ANTERIOR SURFACE OF THE LENS. THE REST OF THE LENS IS WELL AND TRANSPARENT IN THE BAG, AND THERE ARE NO INFLAMMATORY PHENOMENA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERFLEX ASPHERIC STANDARD ASPHERIC IOL HQL RAYNER INTRAOCULAR LENSES LTD. 920H 019E8633933

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention