BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERFLEX

    MDR report key: 2888694 · Received December 20, 2012

    Report

    Report Number
    9611165-2012-00084
    Event Type
    Other
    Date Received
    December 20, 2012
    Report Date
    November 28, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    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. ON (B)(6) 2012, THE HEALTHCARE PROFESSIONAL EXPLANTED THE SUPERFLEX 620H INTRAOCULAR LENS. THE HEALTHCARE FACILITY TOOK MICROSCOPE PHOTOS OF THE LENS FOLLOWING EXPLANTATION. THE PICTURES SHOW GRANULAR TYPE DEPOSITS IN THE PUPIL AREA ON THE ANTERIOR IOL SURFACE. THE SUPERFLEX 620H INTRAOCULAR LENS SUBJECT TO THIS REPORT HAS BEEN SENT TO A THIRD PARTY INDEPENDENT TESTING FACILITY FOR ANALYSIS. THE RESULTS OF THIS ANALYSIS WILL BE DOCUMENTED IN A SUPPLEMENTARY REPORT. 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 OS 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 127E77504

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention