BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3 LASER

    MDR report key: 2421092 · Received January 13, 2012

    Report

    Report Number
    3006695864-2012-00001
    Event Type
    Injury
    Date Received
    January 13, 2012
    Date of Event
    November 29, 2011
    Report Date
    December 14, 2011
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). EPITHELIAL INGROWTH. EVALUATION: FIELD SERVICE SPECIALIST (FSS) VISITED THE SITE AFTER THE REPORTED EVENT. HE VERIFIED LASER ENGINE STABILITY, PHYSICIAN SETTINGS, SIDE CUT RETRACE - NO LOOP OR SIDE CUT RETRACE ERROR AT CURRENT SETTING, LOADING DECK ENERGIES, CENTRATION. VERIFIED GEL RASTER AND SIDE CUT ENERGIES IN GEL. SYSTEM MEETS AMO SPECIFICATIONS. CLINICAL DEVELOPMENT MANAGER (CDM) CONTACTED ACCOUNT SEVERAL TIMES TO GET ADDITIONAL INFORMATION AND TO COORDINATE A VISIT TO OBSERVE CASES. AS OF TODAY, THE INFO PROVIDED IN THIS REPORT IS THE ONLY ONE THAT HAS BEEN PROVIDED BY THE ACCOUNT. METHOD: MECHANICAL TEST PERFORMED; VISUAL EXAMINATION. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS (AMO) AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCOUNT REPORTED TWO EPITHELIAL INGROWTH LAST MONTH. EPITHELIAL INGROWTH WAS NOTICED ON (B)(6) 2011 IN OS (LEFT EYE) DURING SLT (SLIT LAMP TEST). PATIENT WAS ON STEROID TREATMENT. ON (B)(6) 2011 EYE WAS RINSED. PRE AND POST BCVA IS 20/25 IN OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS3 LASER HNO AMO MANUFACTURING USA LLC 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention