BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2063722 · Received April 14, 2011

    Report

    Report Number
    1119421-2011-00409
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS RETURNED. THE LENS WAS DAMAGED. BLOOD AND SOLUTION ARE DRIED ON THE LENS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. AN APPROVED CARTRIDGE AND HANDPIECE WERE INDICATED. ROOT CAUSE: THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED BY THE INVESTIGATION. THE OPTICAL PROPERTIES COULD NOT BE VERIFIED DUE TO THE LENS DAMAGE, HOWEVER, THE LENS WAS IN THE 14.0 DIOPTER RANGE. DUE TO THE CONDITION OF THE RETURNED PRODUCT, THIS DAMAGE IS MOST LIKELY HANDLING RELATED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 03/17/2011 BY FAX AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 03/25/2011. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/14/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECH REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO "MECHANICAL FAILURE". THE PT WAS REPORTED TO HAVE A HISTORY OF DRY EYES. IN A F/U, THE SURGEON REPORTED THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE PT REPORTED TO THE SURGEON THAT HER VISION WAS "TERRIBLE" AT DISTANCE AND NEAR. THE PT HAD HER DRY EYES TREATED WITH MEDICATIONS AND PUNCTAL PLUGS. POSTERIOR CAPSULE OPACIFICATION WAS NOTED AND TREATED WITH A YAG LASER PROCEDURE. AN EPI-LASEK PROCEDURE WAS PERFORMED AS AN ENHANCEMENT PRIOR TO THE IOL EXCHANGE. THE SURGEON REPORTED THE EVENT RESOLVED FOLLOWING THE IOL EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 11013590

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention AMVISC| RESTASIS| BLEPHAMIDE UNG