BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 3131129 · Received May 22, 2013

    Report

    Report Number
    9611165-2013-00035
    Event Type
    Other
    Date Received
    May 22, 2013
    Report Date
    November 29, 2012
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN (B)(4) 2012, REPS FROM THE RAYNER VIGILANCE AND RESEARCH AND DEVELOPMENT TEAMS ATTENDED A MEETING WITH THE REPORTING HEALTHCARE PROFESSIONAL. DURING THIS MEETING, THE HEALTHCARE PROFESSIONAL STATED THAT HE BELIEVED THAT THE REPEAT AIR BUBBLE PROCEDURE WAS INTERACTING WITH THE LENS EITHER MECHANICALLY OR CHEMICALLY AND ALSO NOTED THAT THERE WAS GOOD EVIDENCE TO SHOW THAT SURGERY CAUSES A BREAKDOWN OF THE BLOOD AQUEOUS BARRIER. TO RAYNOR'S KNOWLEDGE, THE INTRAOCULAR LENS ASSOCIATED WITH THIS REPORT REMAINS IMPLANTED. DESPITE VARIOUS ATTEMPTS MADE BY VIGILANCE PERSONNEL TO OBTAIN ADDITIONAL INFORMATION ON THE REPORTED EVENT, NO FURTHER DATA HAS BEEN FORTHCOMING FROM THE REPORTING HEALTHCARE PROFESSIONAL. WITHOUT THE ABILITY TO EXAMINE THE DEVICE AND WITHOUT CLEAR EVENT DETAILS BEING PROVIDED, A FAILURE MODE AND ROOT CAUSE CANNOT BE ASCERTAINED. RAYNER INTRAOCULAR LENSES LIMITED ARE UNABLE TO VERIFY THE REPORTED CASE OF OPACIFICATION.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM KENT AND CANTERBURY HOSPITAL OF AN EVENT THAT OCCURRED FOLLOWING DESCEMET'S STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY (DSAEK) SURGERY AND REPEAT AIR BUBBLE SURGERY. THE EVENT DESCRIPTION PROVIDED INDICATES THAT THE HEALTHCARE PROFESSIONAL OBSERVED THE DEVELOPMENT OF OPACIFICATION IN THE IMPLANTED RAYNER INTRAOCULAR LENS FOLLOWING THESE ADDITIONAL SURGICAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226479 UNK HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention