BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2833707 · Received November 12, 2012

    Report

    Report Number
    1119421-2012-01391
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 10, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2012. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE EXPERIENCED BLURRY VISION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE TECHNICIAN WHO REPORTED THE PATIENT ALSO PRESENTED WITH DYSPHOTOPSIA AND DOUBLE VISION. POSTERIOR CAPSULAR OPACIFICATION (PCO) WAS ALSO NOTED. THE LENS WAS SUBSEQUENTLY EXCHANGED AND THE EVENTS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH. LTD. /HUNTINGTON SN6AD1 10953161

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention