BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1222074 · Received November 6, 2008

    Report

    Report Number
    2023826-2008-01362
    Event Type
    Injury
    Date Received
    November 6, 2008
    Report Date
    October 14, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN 2008, IN THE PATIENT'S RIGHT (OD) EYE. THE SURGEON REPORTED, THE LENS HAD A LOW VAULT AND THERE WAS A PROGRESSED ANTERIOR SUBCAPSULAR CATARACT, AS WELL AS A REFRACTIVE SURPRISE. THE SURGEON HAD SUGGESTED CATARACT EXTRACTION AND IOL IMPLANTATION.

    Devices

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

    Patients

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