BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 4130412 · Received September 30, 2014

    Report

    Report Number
    2023826-2014-00764
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: COLLAMER® ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. EVENT PROBLEM CODES: (B)(4). EVALUATION CODES: METHOD - LENS WORK ORDER SEARCH. RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A SMALL TEAR IN THE LENS OPTIC. LENS WAS RETURNED IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY, LENS WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, THE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO PATIENT'S ANATOMY AND WAS NOT LENS RELATED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS IN THE PATIENT'S RIGHT EYE. AFTER LENS INSERTION THE LENS DID NOT SET WELL IN THE EYE. THE SURGEON CHANGED HIS MIND AND DECIDED TO REMOVE THE LENS AND IMPLANT A STAAR THREE-PIECE LENS. THERE WAS NO PATIENT INJURY. THE SURGEON STATED THERE WERE NO ISSUES WITH THE LENS. THIS INCIDENT WAS DUE TO PATIENT ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609253 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL AND LOT NUMBER - UNK| INJECTOR MODEL AND LOT NUMBER - UNK