BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3841035 · Received May 14, 2014

    Report

    Report Number
    1119421-2014-00331
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 22, 2013
    Report Date
    April 15, 2014
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 FILE INDICATED THE USE OF CARTRIDGE, HANDPIECE, AND VISCOELASTIC. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEW FOR THE CARTRIDGE/HANDPIECE LOT BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE CARTRIDGE IS NOT QUALIFIED FOR USE IN THE REPORTED HANDPIECE. IT IS UNK WHICH VISCOELASTIC WAS USED IN THE CARTRIDGE. A FAILURE TO FOLLOW TH DFU WAS INDICATED BY THE USE OF A HANDPIECE THAT IS NOT QUALIFIED FOR THE LENS/CARTRIDGE COMBINATION, WHICH MAY RESULT IN DELIVERY DIFFICULTIES OR PRODUCT DAMAGE. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE COMPLAINT. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 04/15/2014 AND ADDITIONAL INFO WAS RECEIVED VIA PHONE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2014. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, A PT EXPERIENCED GHOSTING, SHADOWS, HALOS, BLURRED VISION, AND FOGGY VISUAL ACUITY. THE LENS WAS EXCHANGED. THE PT IS REPORTED TO BE "DOING BETTER". THERE ARE TWO MFR REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288001 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12153155

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention DUREZOL| SYSTANE| NEVANANC| MONARCH HANDPIECE| MONARCH CARTRIDGE| DUOVISC| VIGAMOX