BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3133015 · Received May 24, 2013

    Report

    Report Number
    1119421-2013-00567
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 29, 2013
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS OT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE CUSTOMER INDICATED THE USE OF AN APPROVED CARTRIDGE, HANDPIECE AND VISCOELASTIC COMBINATION. THE CARTRIDGE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. A COMPLETED QUESTIONAIRE WAS RECEIVED ON (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED REFRACTIVE OUTCOME AFTER IMPLANTING AN INTRAOCULAR LENS (IOL). THE SURGEON WAS TARGETING APPROX -2.25 TO -2.50 DIOPTERS, BUT THE PT AT ONE WEEK AND ONE MONTH POSTOPERATIVELY WAS -4.0 DIOPTERS. IN A F/U, THE SURGEON REPORTED THE EVENT CONTINUES. IN THE OPINION OF THE SURGEON, THE LENS DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232721 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 12080646

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other MONARCH II HANDPIECE| MONARCH B CARTRIDGE| DUOVISC