BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3931805 · Received June 24, 2014

    Report

    Report Number
    1119421-2014-00488
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 18, 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

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 INTRAOCULAR LENSES (IOL) WERE IMPLANTED BILATERALLY IN A PATIENT. TWO MONTHS AFTER IMPLANTATION IN THE RIGHT EYE, THE SURGEON NOTICED CELLS GROWING ONTO THE ANTERIOR SURFACE OF THE IOL. FIVE MONTHS LATER SHE TREATED THE CELLS WITH A YAG LASER PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368945 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 12186308

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention LISINOPRIL| DUREZOL 04/19/2013-05/08/2013| DUOVISC| VIGAMOX 04/17/2013-04/24/2013| FAMOTIDINE| HYDROCHLOROTHIZAIDE| MAXITROL 04/18/2013-04/24/2013| NEVANAC 04/17/2013-05/08/2013| METOPROLOL| AMLODIPINE| ASPIRIN| OCUVITE| TRIAMTERENE| VISCOAT| SIMVASTATIN| SYSTANE GEL