BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2992518 · Received March 4, 2013

    Report

    Report Number
    1119421-2013-00211
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    November 1, 2012
    Report Date
    February 4, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. MEDICAL RECORDS WERE RECEIVED ON (B)(4) 2013. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON ORIGINALLY REPORTED THAT ABOUT FIFTEEN OF HER PTS HAD TO HAVE EARLY YAG CAPSULOTOMY DUE TO HAZING ON THE ANTERIOR SURFACE OF THE LENS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SOME CASES WERE WORSE THAN OTHERS, AND ALL OCCURRED WITHIN THE PAST FOUR MONTHS. THE PTS WERE NOTED TO BE DOING WELL POSTOPERATIVELY. MEDICAL RECORDS WERE RECEIVED FROM THE SURGEON FOR NINE PTS. FOR THIS PT, MEDICAL RECORDS FROM THE FIRST POSTOPERATIVE DAY ONLY WERE RECEIVED WHICH SHOWED THE PT DOING WELL. THE PT REPORTED SOME PAIN FOR A FEW HOURS FOLLOWING HER IOL IMPLANT THAT HAD IMPROVED BY THE FIRST POSTOPERATIVE DAY. THE PT WAS BILATERALLY IMPLANTED. THERE ARE TWELVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THE MDR FOR THE FOUR REMAINING UNK PTS WAS FILED UNDER MFR REPORT NUMBER 1119421-2012-01555. THIS FILE IS FOR THE THIRD PT, RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91637 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 12184565

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention