BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1033606 · Received April 24, 2008

    Report

    Report Number
    2023826-2008-00584
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 9, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN THE PT'S LEFT (OS) EYE IN 2007. THE LENS WAS EXPLANTED IN 2008 DUE TO EXCESSIVE VAULTING. THE LENS WAS EXCHANGED FOR A SHORTER LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL CO. ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention FOAM TIP PLUNGER MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK