BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3900378 · Received June 27, 2014

    Report

    Report Number
    2023826-2014-00483
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - DEVICE HISTORY REPORT REVIEW. RESULTS - DEVICE HISTORY REPORT REVIEW: EVALUATION OF THE MANUFACTURING, PACKAGING AND STERILIZATION OF LENSES PRODUCED UNDER WORK ORDER HAS SHOWN NO IRREGULARITY FOUND IN THE RAW MATERIALS, MANUFACTURING, STERILIZATION AND PACKAGING WHICH WOULD HAVE CONTRIBUTED TO THE ROOT CAUSE OF THIS COMPLAINT. AFTER REVIEWING THE COMPLAINT FILE, PRODUCT EVALUATION, DEVICE HISTORY RECORD AND PERFORMING A ROOT CAUSE ANALYSIS, QUALITY ENGINEERING CONCLUDES THAT THE MOST LIKELY ROOT CAUSE OF A BENT HAPTIC WOULD HAVE BEEN FROM USER ERROR OR SURGICAL MANIPULATION AT THE FACILITY. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): THE LENS PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH AND DEVICE HISTORY REPORT REVIEW, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT; (LOOP HAPTIC WOULD NOT EXPAND). EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS INTO PATIENT'S RIGHT EYE. THE LOOP HAPTIC WOULD NOT EXPAND AFTER INSERTION. THE PHYSICIAN DECIDED TO REMOVE THE LENS AND IMPLANTED A BACKUP LENS. THERE WAS NO PATIENT INJURY. POSSIBLE LENS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376594 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR INJECTOR MODEL AND LOT NUMBER - UNK| CARTRIDGE MODEL AND LOT NUMBER- UNK