BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2233423 · Received September 2, 2011

    Report

    Report Number
    2023826-2011-00734
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 10, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD REVIEW. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING, PACKAGING, STERILIZATION AND SHIPPING PROCESSES OF THIS LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS TORN INTO TWO PIECES. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST LIKELY ROOT CAUSE OF THE EVENT WOULD BE DUE TO MISHANDLING OF THE LENS AT THE FACILITY. (B)(4).

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC) WITH TORIC OPTIC. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE 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. LENS NOT RETURNED.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON OPENED THE TRAY OF AN AA4203TL TORIC SILICONE SINGLE PIECE LENS AND NOTED THE LENS WAS TORN. THE LENS WAS NOT LOADED OR USED AND THERE WAS NO PATIENT CONTACT. ANOTHER SAME MODEL LENS WAS IMPLANTED. THE REPORTER STATED THE SURGEON INDICATED THE LENS WAS RECEIVED DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK