BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3082482 · Received April 25, 2013

    Report

    Report Number
    1119421-2013-00448
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    January 1, 2012
    Report Date
    February 12, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH BLURRY VISION FOLLOWING A MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADD'L INFO WAS RECEIVED THAT INDICATED THE IOL WAS EXCHANGED TO A MONOFOCAL LENS DUE TO PERSISTENT GLARE AND HALOS. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178361 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12072064

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention