BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERFLEX ASPHERIC

    MDR report key: 3925398 · Received June 16, 2014

    Report

    Report Number
    9611165-2014-00058
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 10, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER HAS ALLOCATED THE REFERENCE (B)(4) TO THIS CASE. THE HEALTHCARE PROFESSIONAL REPORTS THAT FUCH'S ENDOTHELIAL DYSTROPHY WAS PRESENT PRIOR TO THE CATARACT PROCEDURE AND THAT IN 2013 BULLOUS KERATOPATHY WAS OBSERVED. A DMEK PROCEDURE WAS CARRIED OUT ON (B)(4) 2013 AND DURING THIS SURGERY PROBLEMS WERE ENCOUNTERED IN GETTING THE DMEK LENTICLE TO ADHERE TO THE POSTERIOR STROMA. IN RESPONSE TO THIS A "RE-BUBBLING" OF THE ANTERIOR CHAMBER WAS PERFORMED. FOLLOWING DETECTION OF A PERSISTENT DETACHED LENTICLE THE ANTERIOR CHAMBER WAS FILLED WITH A 20% MIXTURE OF SF6 GAS AND AIR TO PROLONG THE GAS TAMPONADE OF THE LENTICLE. THIS PROCEDURE PROVED SUCCESSFUL IN ATTACHING THE LENTICLE; HOWEVER, POST-OPERATIVELY THERE WAS GRAFT FAILURE. A REPEAT DSAEK PROCEDURE WAS THEN CARRIED OUT ON (B)(6) 2013. THE PT WAS FOLLOWED UP IN THE OUTPATIENT CLINIC ON (B)(6) 2013, (B)(6) 2014, . OPACIFICATION OF THE ANTERIOR SURFACE OF THE IOL WAS OBSERVED FOR THE FIRST TIME AT THE (B)(6) 2014 VISIT. OPACIFICATION HAS LED TO A SIGNIFICANT DECREASE IN THE PT'S VISION. THE HEALTHCARE PROFESSIONAL STATES THAT IT IS HIS INTENTION TO EXPLANT THE SUPERFLEX ASPHERIC 920H IOL. FOLLOWING EXPLANATION, THE LENS WILL BE MADE AVAILABLE TO RAYNER FOR ANALYSIS. THE RESULTS OF THE DEVICE ANALYSIS AND ANY ADDITIONAL INVESTIGATION ACTIONS PERFORMED WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A (B)(6) HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A SUPERFLEX ASPHERIC 920H INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED THE 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
    351933 SUPERFLEX ASPHERIC INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 920H 107E76382

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention