BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE IFS

    MDR report key: 2537438 · Received April 17, 2012

    Report

    Report Number
    3006695864-2012-00064
    Event Type
    Injury
    Date Received
    April 17, 2012
    Date of Event
    January 28, 2012
    Report Date
    March 17, 2012
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED THE FOLLOWING SECTIONS: DATE OF THIS REPORT: 03/17/2012. PATIENT INTERFACE, LOT# CJ01284. DATE RECEIVED BY MANUFACTURER: 03/17/2012.

    Additional Manufacturer Narrative · 1

    PATIENT INTERFACE, LOT #CJ01390; EXP. 2013-09; PATIENT INTERFACE, LOT UNKNOWN. THE SYSTEM WAS CHECKED AND FOUND TO BE WITHIN SPECIFICATIONS. IT WAS NOTED THAT THE TEMPERATURE WENT AS LOW AS 12.5 DEGREES CELSIUS AND THE REQUIRED AMBIENT ROOM TEMPERATURE SHOULD BE BETWEEN 19 AND 23 DEGREES CELSIUS. A REVIEW OF THE MANUFACTURING RECORDS FOR THE PATIENT INTERFACE, LOT NUMBER CJ01390 WAS CONDUCTED AND THE DOCUMENTATION SHOWS THAT THE PRODUCT WAS MANUFACTURED WITHIN SPECIFICATIONS. AN ADDITIONAL SYSTEM WAS ALSO CHECKED AND FOUND TO BE WITHIN SPECIFICATIONS (INTRALASE IFS; 20005K, SERIAL #(B)(4); DEVICE MANUFACTURE DATE OCTOBER 2008). PLACEHOLDER.

    Description of Event or Problem · 1

    SITE REPORTED RECENT PROBLEMS WITH POST OPERATIVE INFLAMMATION ONE (1) DAY POST OPERATIVE INTRALASE FLAP CREATION. SURGERY DATE: (B)(6) 2012. EYE: BILATERAL STAGE 1 DIFFUSE LAMELLAR KERATITIS (DLK). INTERVENTION: INCREASED TO HOURLY STEROIDS FOR ONE WEEK. PROGRESS: AS OF (B)(6) RESOLVED. MEDICATION - LEVOFLOXACIN; DEXAMETHASONE MINIMS; CLINITAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE IFS FEMTOSECOND LASER HNO AMO MANUFACTURING USA, LLC. 20005K

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention