BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1252106 · Received December 4, 2008

    Report

    Report Number
    2023826-2008-01451
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    August 13, 2008
    Report Date
    November 5, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER (IRIDECTOMY),

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN 2008 IN THE PATIENT'S LEFT (OS) EYE. THE LENS WAS EXPLANTED ON ELEVEN DAYS LATER, DUE TO EXCESSIVE VAULTING. SUBSEQUENTLY, THE PATIENT EXPERIENCED ELEVATED IOP, NARROWING OF THE ANGLE, ANGLE CLOSURE AND SHALLOWING OF THE ANTERIOR CHAMBER. THE PATIENT ALSO HAD BLURRED VISION. AN IRIDECTOMY WAS PERFORMED. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL CO ICM125V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention INJECTOR: MODEL AND LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK