BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3914416 · Received July 3, 2014

    Report

    Report Number
    2023826-2014-00516
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 17, 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

    METHOD: DEVICE HISTORY REPORT REVIEW. RESULTS: DEVICE HISTORY REPORT REVIEW: BASED ON THE PRODUCT EVALUATION AND THE INVESTIGATION THAT WAS PERFORMED, NOTHING IN THE MANUFACTURING, PACKAGING OR STERILIZATION WAS FOUND TO BE THE ROOT CAUSE OF THIS COMPLAINT. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND DEVICE WORK ORDER SEARCH, DEVICE HISTORY REPORT REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE PLATE HAPTIC AND OPTIC IS TORN. THERE ARE SMALL SCRATCHES ON HAPTIC AND OPTIC. LENS WAS RETURNED IN LIQUID. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4)- NO CONSEQUENCES OR IMPACT TO PATIENT; DEFECTIVE LENS, NICK ON LENS. 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 LENS WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: REPORTER STATED THE LENS WAS RECEIVED DEFECTIVE. A NICK WAS NOTED ON THE OPTIC WHEN THE LENS WAS TAKEN OUT OF THE VIAL. THE PLATE HAPTIC WAS TORN DURING HANDLING OF THE LENS. THERE WAS NO ATTEMPT TO LOAD THE LENS.

    Description of Event or Problem · 1

    THE REPORTER STATED THE A CC4204A COLLAMER SINGLE PIECE LENS LOOKED LIKE IT HAD A NICK. NO PATIENT CONTACT. FURTHER INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE. NO PATIENT OR DATE OF SURGERY INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390762 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR