BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1923782 · Received December 1, 2010

    Report

    Report Number
    2023826-2010-01227
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS - THE VISUAL INSPECTION SHOWED ONLY A PIECE OF THE OPTIC AND HAPTIC WERE RETURNED. THE RESULT OF THE LENS WAS TORN OFF AND MISSING. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED, THE CC4204A COLLAMER SINGLE PIECE LENS TORE DURING INSERTION. THE LENS WAS CUT OUT OF THE EYE AND REPLACED WITH THE SAME MODEL LENS WITHOUT ANY PT INJURY. THE REPORTER STATED, THE INCIDENT WAS THE RESULT OF A LOADING ISSUE.

    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. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR NANOPOINT INJECTOR: LOT# UNK| NANOPOINT CARTRIDGE: LOT# UNK