BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3872154 · Received June 13, 2014

    Report

    Report Number
    2023826-2014-00454
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 19, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(6) - NO KNOWN CONSEQUENCES OR IMPACT TO THE PATIENT; TORN MATERIAL; WRINKLED. EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: A PARENT/CHILD LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. CONCLUSION - (UNABLE TO CONFIRM): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. THE LENS WAS DISCARDED. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CC4204A COLLAMER SINGLE PIECE LENS WAS LOADED AND UPON ADVANCEMENT THE SURGEON NOTICED THE LENS WAS RIPPED AND WRINKLED. THE TIP OF THE CARTRIDGE TOUCHED THE EYE BUT NOT THE LENS. THERE WAS NO PATIENT INJURY AND THE LENS WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349865 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR NANOPOINT INJECTION SYSTEM, LOT NUMBER UNKNOWN