BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSERT, RHOMBUS INJECTOR CARTRIDGE

    MDR report key: 37674 · Received September 5, 1996

    Report

    Report Number
    2027189-1996-00003
    Event Type
    Injury
    Date Received
    September 5, 1996
    Report Date
    September 5, 1996
    Manufacturer
    CHIRON VISION CORP.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A2-4: PATIENT AGE/DATE OF BIRTH/WEIGHT/SEX NOT PROVIDED BY USER FACILITY TO INTERNATIONAL AFFILIATE. D5: UNABLE TO DETERMINE EXPIRATION DATE BECAUSE ACCOUNT WAS NOT ABLE TO PROVIDE LOT NUMBER OF THE DEVICE. D6: ACCOUNT WAS NOT ABLE TO PROVIDE LOT NUMBER OF THE DEVICE. E1: INTERNATIONAL FACILITY, NO AREA CODE. H4: UNABLE TO DETERMINE MFR DATE BECAUSE ACCOUNT WAS NOT ABLE TO PROVIDE LOT NUMBER OF THE DEVICE. H3: PRODUCT EVALUATION RESULTS: INSERTION DEVICE WAS NOT RETURNED FOR EVALUATION. EVALUATION OF THE RETURNED LENS SHOWED THAT THERE WAS NOT DAMAGE TO THE LENS.

    Description of Event or Problem · 1

    THE LENS DID NOT FULLY RELEASE FROM THE CARTRIDGE CAUSING THE SURGEON TO WITHDRAW THE DEVICE FROM THE EYE WITH THE LENS STILL ATTACHED TO THE INSERTER TIP. THE INCISION WAS ENLARGED RELATED TO THE EVENT FOR INSERTION OF A PMMA STYLE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSERT, RHOMBUS INJECTOR CARTRIDGE LENS, INTRAOCULAR (INSERTION DEVICE) HQL CHIRON VISION CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention