BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE

    MDR report key: 2912282 · Received January 11, 2013

    Report

    Report Number
    2648035-2013-00012
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - THERE WAS LOSS OF SUCTION AFTER THE LASER FIRED/DURING THE PROCEDURE. THERE WAS NO LOSS TO BEST CORRECTED VISUAL ACUITY (BCVA). NO PATIENT INJURY. SURGEON SWITCHING TO PHOTOREFRACTIVE KERATECTOMY (PRK) WAS NOT TO PREVENT A SERIOUS INJURY. SYSTEM# ((B)(4)) WAS EVALUATED ON (B)(6) 2012 AND THE SYSTEM MEETS ALL AMO SPECIFICATIONS. A MANUFACTURING RECORD REVIEW/DEVICE HISTORY RECORD WAS CONDUCTED FOR LOT #CK01359. NO NONCONFORMANCES WERE DOCUMENTED. DOCUMENTATION SHOWS THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 1 PATIENT INTERFACE (CK01359) DUE TO SUCTION LOSS AFTER THE LASER FIRED. TREATMENT WAS ABORTED AND PATIENT WAS SWITCHED TO PHOTOREFRACTIVE KERATECTOMY (PRK). THE SUCTION ISSUE WAS NOT CAUSED BY EXCESSIVE FLUIDS ON THE EYE. THERE WAS NO PATIENT MOVEMENT DURING THE PROCEDURE. THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18901 INTRALASE FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS PI-RET CK01359

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INTRALASEFS2 LASER MODEL:20003D SERIAL#: (B)(4)| INTRALASE FS2, MODEL # 20003D, LOT# 0806-40092