BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2476573 · Received March 1, 2012

    Report

    Report Number
    1119421-2012-00274
    Event Type
    Injury
    Date Received
    March 1, 2012
    Date of Event
    December 23, 2011
    Report Date
    January 31, 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
    OH, 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. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. ADD'L INFO WAS REQUESTED BY PHONE, FAX AND MAIL ON 2/1/2012 AND 2/21/2012. ADD'L INFO WAS RECEIVED ON 2/9/2012 AND 2/21/2012. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECH REPORTED A PT THAT WAS SEEING HALOS, STARBURSTS AND COULD SEE REFLECTIONS OF THE LENS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. IN A F/U, A SURGICAL TECH REPORTED THAT THIS LENS WAS EXCHANGED WITH A DIFFERENT MODEL. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENTS. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN6AD1 10872554

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention HANDPIECE| MONARCH CARTRIDGE| VISCOELASTIC