BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE

    MDR report key: 3016013 · Received March 21, 2013

    Report

    Report Number
    2648035-2013-00127
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE - THE RETURNED PATIENT INTERFACE WAS SENT TO THE MANUFACTURING FACILITY FOR VISUAL, FUNCTIONAL AND DIMENSIONAL TESTING. THE COMPLAINT FOR ABORTED/INTERRUPTED SUCTION LOSS WAS NOT VERIFIED. THE PRODUCT MET THE ACCEPTANCE CRITERIA. HOWEVER, DIMENSIONAL TESTING COULD NOT BE PERFORMED SINCE THE CONE WAS NOT RETURNED. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING RECORD REVIEW WAS PERFORMED, INDICATING THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS WITH NO NONCONFORMANCE DOCUMENTED. . PLACEHOLDER.

    Description of Event or Problem · 1

    ONE PATIENT INTERFACE (PI) LOT NUMBER CK01273 WAS RETURNED DUE TO SUCTION LOSS ON THE LEFT EYE (OS) AFTER THE LASER HAD FIRED. DOCTOR LOST SUCTION 4 TIMES DURING POCKET CREATION THEN SWITCHED OUT THE RING. WITH THE NEW RING DOCTOR WAS NOT ABLE TO OBTAIN SUCTION. DOCTOR ABORTED INTRALASE AND AT THAT POINT THE PATIENT WAS SWITCHED TO PHOTOREFRACTIVE KERATECTOMY (PRK). PATIENT'S PRE-OP BEST CORRECTED VISUAL ACUITY WAS 20/25-2. PATIENT'S POST-OP BEST CORRECTED VISUAL ACUITY WAS 20/30-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118717 INTRALASE INTRALASE PATIENT INTERFACE HNO ABBOTT MEDICAL OPTICS CK01273

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other