BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2250204 · Received September 15, 2011

    Report

    Report Number
    2023826-2011-00791
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Report Date
    August 17, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATIONRESULTS:VISUAL INSPECTION OF THE RETURNED LENS SHOWED EVIDENCE OF A CLEAR SURGICAL RESIDUE, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE LENS. CONCLUSION:BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND PRODUCT EVALUATION, WE WERE UNABLE TO CONFIRM THIS COMPLAINT. (B)(4)

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT, TORN, SPLIT, CRACKED. EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND WITHIN THE WORK ORDER. CONCLUSION: BASED ON THE COMPLAINTS HISTORY AND WORK ORDER SEARCH, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE AQ2015A SILICONE THREE PIECE LENS WAS PARTIALLY INSERTED INTO THE EYE BEFORE THE SURGEON NOTED THE HAPTIC HAD BEEN TORN. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY AND REPLACED WITH THE SAME MODEL LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2015A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 EPIPHANY INJECTION SYSTEM, LOT NUMBER UNKNOWN