BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2122109 · Received May 24, 2011

    Report

    Report Number
    2023826-2011-00441
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON INSERTED A (B)(4) COLLAMER ASPHERIC SINGLE PLATE LENS. LENS TORE UPON INSERTION INTO THE EYE. LENS WAS CUT TO REMOVE FROM THE EYE. NO WIDENED INCISION AND NO SUTURE USED. NO PT INJURY. REPORTER STATED, INCIDENT WAS DUE TO LOADING ERROR BY THE SURGEON.

    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 CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR INJECTOR SYSTEM MODEL - NANOPOINT - LOT #UNK