BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1000723 · Received February 21, 2008

    Report

    Report Number
    2023826-2008-00237
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 29, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS BUT THE LENS BECAME STUCK IN THE CARTRIDGE AND THE SURGEON WAS UNABLE TO PUSH THE LENS THROUGH. WHEN THE SURGEON WAS ABLE TO PUSH THE LENS OUT, THE HAPTICS WERE TORN OFF. THERE WAS NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL CO. MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL AND NUMBER UNK| FOAM TIP PLUNGER MODEL AND LOT # UNK| CARTRIDGE MODEL AND LOT NUMBER UNK