BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1120014 · Received August 14, 2008

    Report

    Report Number
    2023826-2008-01072
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 28, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A CC4204BF COLLAMER SINGLE PIECE LENS BUT THE INJECTOR PLUNGER OVERRODE AND TORE THE LENS IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT OR INJURY. ANOTHER LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL: NANOPOINT| INJECTOR MODEL: NANOPOINT