BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FEMTOSECOND LASER

    MDR report key: 2145800 · Received June 23, 2011

    Report

    Report Number
    3006695864-2011-00049
    Event Type
    Injury
    Date Received
    June 23, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARTICLE CITATION: MAJID MOSHIRFAR, MD; JOURNAL OF CATARACT & REFRACTIVE SURGERY (2010;36:1925-1933). (B)(4). (SUCTION LOSS LEADING TO INCOMPLETE FLAP, DISLODGED FLAP, MAJOR EPITHELIAL DEFECT/SLOUGHING, TORN FLAPS, TLSS AND PHOTOPHOBIA, VERTICAL GAS BREAKTHROUGH OR BUTTONHOLE, GAS BUBBLE IN ANTERIOR CHAMBER, DECENTERED FLAP, EPITHELIAL INGROWTH); DLK (STATE I-II). NO INFORMATION AT THE TIME. DR. (B)(6) WAS CONTACTED ON (B)(6) 2011 AND HE RESPONDED THAT HE WAS GOING TO BE OUT OF THE COUNTRY AND ON HIS RETURN HE WILL BE PROVIDING MORE INFORMATION. INVESTIGATION IS BEING CONDUCTED TO IDENTIFY THE EQUIPMENT. THE INFORMATION AT THIS TIME IS THAT FLAP LIFT AND RINSE WAS DONE ON PATIENTS THAT EXPERIENCED EPITHELIAL INGROWTH 6 WEEKS AFTER SURGERY. FINAL CDVA FOR THE PATIENTS WAS LESS OR EQUAL TO 20/20. EVALUATION, RESULTS/CONCLUSION: NO INFORMATION AT THE TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011 COPY OF AN ARTICLE FROM JOURNAL OF CATARACT AND REFRACTIVE SURGERY (2010; 36:1925-1933) WAS FORWARDED TO PRODUCT SAFETY. ARTICLE TITLE IS 'LASER IN SITU KERATOMILEUSIS FLAP COMPLICATIONS USING MECHANICAL MICROKERATOME VERSUS FEMTOSECOND LASER: RETROSPECTIVE COMPARISON'. ARTICLE MENTIONED THAT 137 OUT OF 902 EYES HAD SOME COMPLICATIONS. COMPLICATIONS REPORTED WERE AS FOLLOWS: DLK I-II (96 EYES), SUCTION LOSS LEADING TO INCOMPLETE FLAP (10 EYES), DISLODGED FLAPS (10 EYES), MAJOR EPITHELIAL DEFECT/SLOUGHING (5 EYES), TORN FLAPS (4 EYES), TLSS AND PHOTOPHOBIA (4 EYES - BOTH EYES OF 2 PATIENTS), VERTICAL GAS BREAKTHROUGH OR BUTTONHOLE (3 EYES), GAS BUBBLE IN AC (3 EYES), DECENTERED FLAP (1 EYE), EPITHELIAL INGROWTH (1 EYE). NO PATIENT IDENTIFIERS HAVE BEEN SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention