BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3093618 · Received May 1, 2013

    Report

    Report Number
    1119421-2013-00472
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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. CUSTOMER INDICATED THE USE OF AN APPROVED CARTRIDGE. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED FOR THE CARTRIDGE, BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING 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 ADDITIONAL INFORMATION BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2013. (B)(4).

    Description of Event or Problem · 1

    AN ADMINISTRATIVE ASSISTANT REPORTED THAT A PATIENT HAD AN UNEXPECTED POSTOPERATIVE REFRACTIVE OUTCOME AFTER HAVING A MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANTED. THE LENS WAS EXCHANGED FOR A LENS OF THE SAME MODEL BUT DIFFERENT POWER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON, WHO REPORTED THAT THE EVENT RESOLVED WITH TREATMENT (LENS EXCHANGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190077 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12065373

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention MONARCH HANDPIECE| MONARCH D CARTRIDGE| VISCOAT