BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1022544 · Received March 27, 2008

    Report

    Report Number
    2023826-2008-00438
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 7, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A CC4204BF COLLAMER SINGLE PIECE LENS BUT THE LENS BECAME STUCK IN THE CARTRIDGE. THERE WAS NO PT CONTACT OR INJURY. THE REPORTER STATED THE CAUSE OF THE LENS BECOMING STUCK IN THE CARTRIDGE WAS DUE TO A LOADING ERROR.

    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 CO. CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL SFC-25 FP - LOT NUMBER UNK| INJECTOR MODEL INDIGO-P - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP INDIGO - LOT NUMBER UNK