BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2894783 · Received December 20, 2012

    Report

    Report Number
    1119421-2012-01606
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    September 1, 2012
    Report Date
    November 30, 2012
    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
    IL, US
    Reporter Occupation
    OTHER

    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. ADDITIONAL INFO WAS PROVIDED ON THE ATTACHED QUESTIONNAIRE, WHICH INDICATED AN APPROVED CARTRIDGE WAS USED. NOT ENOUGH INFO WAS PROVIDED TO PRODUCT A REVIEW ON THE CARTRIDGE LOT. 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 INFO. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(6) /2012. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING A MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PT REPORTS POOR NEAR AND INTERMEDIATE VISION. IN A FOLLOW UP, THE SURGEON REPORTED THE EVENT CONTINUES. THE PT'S VISUAL ACUITY IS 20/20 DISTANCE UNCORRECTED. THE SURGEON REPORTED THE LENS WILL NOT BE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12097467

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other PRED FORTE| MONARCH B CARTRIDGE| VIGAMOX| PROVISC| NEVANAC| VISCOAT| UNK MONARCHHANDPIECE