BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOT AVAILABLE

    MDR report key: 3844633 · Received May 9, 2014

    Report

    Report Number
    9611165-2014-00055
    Event Type
    Other
    Date Received
    May 9, 2014
    Report Date
    April 17, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES LIMITED HAS ALLOCATED THE REFERENCE (B)(4) TO THIS CASE. THE HEALTHCARE PROFESSIONAL REPORTS THAT THE DEVELOPMENT OF "BROWNISH OPACIFICATION" HAS OCCURRED THREE YEARS POST IOL IMPLANTATION. ON (B)(4) 2014, THE (B)(4) DISTRIBUTOR NOTIFIED RAYNER THAT THE HEALTHCARE PROFESSIONAL WAS ARRANGING A CONSULTATION WITH THEIR PT IN ORDER TO PROVIDE PHOTOGRAPHS TO RAYNER FOR EVAL. RAYNER HAS REQUESTED ADD'L INFO TO AID THE INVESTIGATION OF THE REPORTED DEVELOPMENT OF OPACIFICATION FROM THE BRAZILIAN DISTRIBUTOR. THE DISTRIBUTOR IS LIAISING WITH THE HEALTHCARE PROFESSIONAL TO OBTAIN THE REQUESTED INFO. TO DATE, NO INFO OTHER THAN THAT PROVIDED IN THIS REPORT HAS BEEN MADE AVAILABLE TO RAYNER. WITHOUT THE ABILITY TO EXAMINE THE DEVICE AND WITHOUT CLEAR EVENT DETAILS BEING PROVIDED IT IS NOT POSSIBLE TO ASCERTAIN A ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM THE (B)(4) DISTRIBUTOR OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED STATES THAT THE HEALTHCARE PROFESSIONAL OBSERVED THE DEVELOPMENT OF A "BROWNISH OPACIFICATION" ON THE LENS IN THE POST-OPERATIVE PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282038 NOT AVAILABLE INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1