BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERFLEX

    MDR report key: 2918204 · Received January 9, 2013

    Report

    Report Number
    9611165-2013-00003
    Event Type
    Other
    Date Received
    January 9, 2013
    Report Date
    December 11, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LIMITED. THE HEALTHCARE FACILITY ADVISED RAYNER THAT THE PT REPORTED THAT THEIR VA WAS NOT AS SHARP POST-OPERATIVELY. THE PTS IMMEDIATE VA POST SUPERFLEX IMPLANTATION WAS 6/6. THE HEALTHCARE FACILITY REPORTED THE VA AT "2ND POST OP 3/25" TO BE 6/12. ON (B)(6) 2012, THE PT UNDERWENT A YAG CAPSULOTOMY. THE HEALTHCARE FACILITY INFORMED RAYNER THAT THE VA POST YAG CAPSULOTOMY WAS 6/6. RAYNER HAS NOT RECEIVED ANY INDICATION FROM THE HEALTHCARE FACILITY OR THE (B)(4) DISTRIBUTOR THAT FURTHER REMEDIAL ACTION IS REQUIRED. WITHOUT THE ABILITY TO EXAMINE THE DEVICE AND WITHOUT CLEAR EVENT DETAILS BEING PROVIDED, A FAILURE MODE AND ROOT CAUSE CANNOT BE ASCERTAINED.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(6) HOSPITAL OF AN EVENT THAT OCCURRED FOLLOWING THE IMPLANTATION OF A SUPERFLEX INTRAOCULAR LENS. THE EVENT DESCRIPTION PROVIDED INDICATES THAT THE PT REPORTED THAT THEIR VISUAL ACUITY (VA) WAS NOT AS SHARP POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12431 SUPERFLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention