BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISION ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1014121 · Received March 13, 2008

    Report

    Report Number
    2023826-2008-00340
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    March 4, 2008
    Report Date
    February 26, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON IMPLANTED A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS IN 2007, IN THE PATIENT'S RIGHT (OD) EYE. THE LENS WAS EXPLANTED IN 2008, DUE TO EXCESSIVE VAULTING. THE PATIENT COMPLAINED OF BLURRED VISUAL ACUITY AND HEADACHES. THE LENS WAS EXCHANGED FOR A SHORTER LENS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR MODEL MSI-PF - LOT NUMBER UNK| CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| FOAM TIP PLUNGER FOAM TIP PLUNGER - LOT NUMBER UNK