BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2506568 · Received March 27, 2012

    Report

    Report Number
    2023826-2012-00177
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Report Date
    March 5, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) - CORRECTION - P880091. METHOD - DEVICE HISTORY RECORD REVIEW. RESULTS - A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING, STERILIZATION AND PACKAGING PROCESSES OF THIS LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT. THE LENS WAS SENT TO S & N LABS AND THE RESULTS OF THE ANALYSIS OF THE BROWN PARTICLE ON THE LENS SURFACE SHOW THAT IT WAS NOT DERIVED FROM ANY MATERIALS USED DURING THE MANUFACTURING, STERILIZATION OR PACKAGING PROCESSES OF THE AQ2010V LENSES AT STAAR SURGICAL. CONCLUSIONS - BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST PROBABLE CAUSE OF THE EVENT WOULD BE THAT THE SPOT WAS CAUSED BY HANDLING AND THE USE OF VISCOELASTIC AT THE CUSTOMER'S FACILITY. (B)(4).

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). (B)(4): EVALUATION: METHOD - LENS WORK ORDER SEARCH. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. BROWN PARTICLES WERE FOUND ON THE LENS SURFACE. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): 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).

    Description of Event or Problem · 1

    THE REPORTER STATED THE TECHNICIAN WAS PREPARING TO LOAD THE LENS, WHEN SHE NOTICED A BROWN SPOT ON THE LENS. THE TECHNICIAN ATTEMPTED TO CLEAN/WIPE OFF THE SPOT BUT WAS UNABLE TO DO SO. THE LENS WAS NOT LOADED AND THERE WAS NO PATIENT CONTACT. THE REPORTER STATED THEY FEEL THE LENS WAS RECEIVED THAT WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V NA

    Patients

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