BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 140037 · Received December 22, 1997

    Report

    Report Number
    1119421-1997-00123
    Event Type
    Injury
    Date Received
    December 22, 1997
    Date of Event
    November 24, 1997
    Report Date
    November 24, 1997
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LENS WAS EVALUATED AND FOUND TO HAVE A SCRAPE MARK ACROSS THE OPTIC. THE MARK WAS FURTHER CONFIRMED IN S.E.M. PHOTOS. REPORTING SURGEON SPOKE WITH AN ALCON CONSULTANT ON HOW TO AVOID DAMAGING LENSES IN THE FURUTRE. THIS REPORT WAS MAILED IN TO FDA ON: 2/5/1998. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. NUMBER OF PERSONS AFFECTED = 1.

    Description of Event or Problem · 1

    SURGEON REPORTS LENS WAS EXPLANTED DUE TO A CRACK IN THE OPTIC WHICH CAUSED THE PT TO EXPERIENCE A WHITE LINE IN HIS VISION. THE PT WAS REPORTED TO BE 20/20 WITH CORRECTION AT 1 DAY POST-OP LENS REPLACEMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF Implant INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. MA30BA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention