BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERFLEX

    MDR report key: 2888693 · Received December 20, 2012

    Report

    Report Number
    9611165-2012-00085
    Event Type
    Other
    Date Received
    December 20, 2012
    Report Date
    November 28, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LTD. THE HEALTHCARE FACILITY PROPOSES TO EXPLANT THE SUPERFLEX 620H INTRAOCULAR LENS SUBJECT TO THIS REPORT IN THE NEXT 2-3 MONTHS. THE DEVICE WILL BE MADE AVAILABLE TO RAYNER FOR ANALYSIS. THE PT HAS HAD REPEAT BILATERAL OCULAR SURGICAL TRAUMA, WITH OCULAR INFLAMMATION OVER A PROLONGED PERIOD OF TIME. THE HEALTHCARE PROFESSIONAL POSTULATED THAT PERHAPS THE COMBINATION OF ENVIRONMENTAL CONDITIONS, MULTIPLE SURGICAL PROCEDURES, AND PT HEALTH COULD BE CAUSATIVE FACTORS.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LTD RECEIVED NOTIFICATION FROM THE (B)(6) OF AN EVENT THAT OCCURRED FOLLOWING THE IMPLANTATION OF A SUPERFLEX 620H INTRAOCULAR LENS IN THE OD EYE. THE EVENT DESCRIPTION PROVIDED INDICATES THAT OPACIFICATION OCCURRED FOLLOWING DESCEMET'S STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY (DSAEK) SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERFLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 620H 0067E73735

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention