BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2842005 · Received November 14, 2012

    Report

    Report Number
    1119421-2012-01411
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ADDITIONAL INFO HAS BEEN REQUESTED BY PHONE, EMAIL AND MAIL ON 10/15/2012, 10/17/2012, 10/22/2012 AND 11/12/2012. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN INFECTION CONTROL COORDINATOR REPORTED THAT THREE DAYS FOLLOWING AN UNEVENTFUL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT PRESENTED WITH PAIN AND VISION LOSS. THE PT WAS REFERRED TO THE EMERGENCY ROOM (ER) AND WAS DIAGNOSED WITH ENDOPHTHALMITIS AND A VITRECTOMY WAS PERFORMED. ORGANISMS CULTURED WERE STREPTOCOCCUS CONSTELLATUS AND STREPTOCOCCUS SANGUINIS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SA60AT 12161030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention