BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3913407 · Received July 3, 2014

    Report

    Report Number
    2023826-2014-00512
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4) - TORN MATERIAL; DEVICE DAMAGED BY ANOTHER DEVICE; EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND REVEALED THERE WERE NO SIMILAR COMPLAINTS WITHIN THE WORK ORDER. CONCLUSION- (UNABLE TO CONFIRM): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, WE WERE UNABLE TO CONFIRM THIS COMPLAINT. THE PRODUCT WAS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER THE +21.5 DIOPTER CC4204A SINGLE PIECE LENS WAS TRAPPED IN THE INSERTER AND CUT INTO PIECES DURING INSERTION. THERE WAS NO PATIENT INJURY. THE CUSTOMER DID NOT KNOW THE CAUSE OF THE EVENT AND COULD NOT PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391089 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASICO INJECTOR, LOT NUMBER UNKNOWN