BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3854571 · Received June 6, 2014

    Report

    Report Number
    2023826-2014-00441
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE LENS WAS INSERTED INTO THE PATIENT'S LEFT EYE AND WAS REMOVED DURING THE SAME PROCEDURE. THE LENS WAS NOT EXPLANTED AT A LATER TIME. NO PATIENT INJURY. NO FURTHER INFORMATION ON DEFECT ON LENS. THERE WAS NO PROBLEM WITH THE INJECTOR SYSTEM. (B)(4): EVALUATION: METHOD - DEVICE HISTORY RECORD REVIEW. RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE OPTIC CUT. LENS WAS RETURNED IN THREE PIECES. PIECES ON EACH PLATE HAPTICS ARE TORN OFF AND MISSING. LENS RETURNED IN THE VIAL WITH LIQUID. RETURNED INJECTOR WITH CARTRIDGE ATTACHED TO INJECTOR. INJECTOR PLUNGER IS TORN. THE CARTRIDGE TIP IS DAMAGED. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE ON INJECTOR AND CARTRIDGE. DEVICE HISTORY RECORD REVIEW: BASED ON THE INVESTIGATION PERFORMED, REVIEW OF THE DEVICE HISTORY RECORD AND ROOT CAUSE ANALYSIS, THE ROOT CAUSE OF THE DEFECTIVE LENS IS UNKNOWN. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, DEVICE HISTORY RECORD 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

    EVENT DATE: UNKNOWN. COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. IMPLANT AND EXPLANT DATE: UNKNOWN. (B)(4) - SURGICAL PROCEDURE, SECONDARY SURGERY. DEFECTIVE 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 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 IMPLANTED A CC4204A COLLAMER SINGLE PIECE LENS IN THE PATIENT'S EYE. THE LENS WAS DEFECTIVE AND WAS REMOVED. ANOTHER LENS SAME DIOPTER AND SIZE WAS IMPLANTED. NO FURTHER INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. A SUPPLEMENTAL WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331987 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention