BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE IFS

    MDR report key: 2475061 · Received March 1, 2012

    Report

    Report Number
    3006695864-2012-00035
    Event Type
    Injury
    Date Received
    March 1, 2012
    Date of Event
    January 19, 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

    PATIENT INTERFACE, LOT #CJ01390, EXP. 2013-09; PATIENT INTERFACE, LOT UNKNOWN, EXP. UNKNOWN. THE SYSTEM WAS CHECKED AND FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THE PATIENT INTERFACE, LOT NUMBER CJ01390 WAS CONDUCTED. THE DOCUMENTATION SHOWS THAT PRODUCTS WERE MANUFACTURED WITHIN SPECIFICATIONS. AN ADDITIONAL SYSTEM WAS ALSO CHECK AND WAS FOUND TO BE WITHIN SPECIFICATIONS (INTRALASE FS2; 20005K, SERIAL #(B)(4)).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT INTERFACE, LOT #CJ01390; EXP. 2013-09; PATIENT INTERFACE, LOT UNKNOWN; AMO EXIMER LASER. 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).

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL SYSTEM WAS ALSO CHECKED AND FOUND TO BE WITHIN SPECIFICATIONS (INTRALASE IFS; 20005K, SERIAL #(B)(4); DEVICE MANUFACTURE DATE OCTOBER 2008).

    Description of Event or Problem · 1

    SITE REPORTED RECENT PROBLEMS WITH POST OP INFLAMMATION ONE DAY POST INTRALASE FLAP CREATION. SITE HAS EXPERIENCED 13 CASES OUT OF 62 TREATMENTS OVER 10 DAYS. TWO OF THE 13 PATIENTS HAVE GONE ON TO DEVELOP CENTRAL TOXIC KERATOPATHY (CTK) AND HAVE REQUIRED FURTHER INTERVENTION. REFER TO MEDWATCH NUMBER 3006695864-2012-00033 FOR THE REPORT OF THE OTHER PATIENT WITH CTK.

    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 CENTRAL TOXIC KERATOPLASTY (CTK). INTERVENTION: INCREASED STEROIDS. PROGRESS: AS OF (B)(6) 2012, THE PATIENTS VISUAL ACUITY IS AT - 6/6 (20/20). 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 1008-60234

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention