BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3931806 · Received June 24, 2014

    Report

    Report Number
    1119421-2014-00490
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 14, 2013
    Report Date
    May 28, 2014
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THREE WEEKS AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, SHE NOTICED CELLS GROWING ONTO THE ANTERIOR SURFACE OF THE IOL CAUSING DECREASED VISION. THREE AND A HALF MONTHS LATER SHE TREATED THE CELLS WITH A YAG LASER PROCEDURE AND THE PATIENT'S VISION IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368747 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 12175108

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention GLUCOMSAMINE| NEVANAC 04(B)(6) 2013| VIGAMOX (B)(6) 2013| TIMOLOL (B)(6) 2013| ALLOPURINOL| TRIAMTERENE| LEVOTHYROXIDE| FAMOTIDENE| LISINOPRIL| METOPROLOL| ADVAIR INHALER| NABUMETONE| MAXITROL (B)(6) 2013| CALCIUM| LOVASTATIN| PROVISC| ASPIRIN| ALBUTEROL INHALER| DUREZOL (B)(6) 2013| OMEPRAZOLE| VITAMIN C| VISCOAT