BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2880979 · Received December 14, 2012

    Report

    Report Number
    9612169-2012-00098
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    June 15, 2010
    Report Date
    November 14, 2012
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE REPORTER PROVIDED TWO IOL SERIAL NUMBERS; HOWEVER, IT WAS NOT SPECIFIED WHICH IOL PERTAINS TO EACH EYE. PRODUCT AND BATCH HISTORY RECORDS WERE REVIEWED FOR THE REPORTED SERIAL NUMBERS AND THE PRODUCTS MET RELEASE CRITERIA. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A GOVERNMENT AGENCY REPORTED THAT A PATIENT EXPERIENCED GLARE DUE TO GLISTENINGS ON THE LENS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THERE WAS A SECONDARY SURGERY TO EXCHANGE THE IOL; HOWEVER, THE SURGEON WAS UNSUCCESSFUL AT REMOVING THE LENS. THE PATIENT WAS SUBSEQUENTLY TREATED WITH LASER TO REMOVE SCAR TISSUE. NO FURTHER TREATMENT WAS PERFORMED. THE PATIENT DID HAVE A SUCCESSFUL IOL EXCHANGE IN THE LEFT EYE. THE PATIENT REPORTED THAT WHILE THE REPLACEMENT LENS HAS A YELLOW TINT, THE LENS IN THE RIGHT EYE HAS A BLUE TINT. ALTHOUGH VERY SATISFIED WITH THE RESULT OF THE EXCHANGE, THE PATIENT FEELS THAT HAVING DIFFERENT LENSES IN EACH EYE IS BOTHERSOME AND HAS CONTRIBUTED TO "NUISANCES" WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS FILE IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60AT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention