BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 799113 · Received December 14, 2006

    Report

    Report Number
    1119421-2006-00414
    Event Type
    Other
    Date Received
    December 14, 2006
    Date of Event
    November 9, 2006
    Report Date
    November 14, 2006
    Manufacturer
    ALCON MANUFACTURING, INC. / HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H.3., 6.: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE SURGEON OBSERVED THE HAPTIC WAS STUCK ON THE SURFACE OF THE LENS. THE DECISION WAS MADE TO LEAVE THE IOL IN PLACE. DURING A POSTOPERATIVE EXAMINATION, IT WAS NOTED THAT THE PATIENT DID NOT HAVE 100% VISUAL FIELD AND THE HAPTIC CONTINUED TO BE STUCK ON THE LENS OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON MANUFACTURING, INC. / HUNTINGTON SA60AT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other