BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 1945620 · Received December 10, 2010

    Report

    Report Number
    3006695864-2010-00134
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    May 6, 2009
    Report Date
    November 18, 2010
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    LZS
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION. CONTACT NAME, CLINIC NAME AND DEVICE IDENTIFIER WERE NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A VOLUNTARY MEDWATCH REPORT WAS REC'D FROM FDA/MAUDE EVENT REPORT, REPORTING THE FOLLOWING INFORMATION: PT WAS INJURED BY LASIK ABOUT 17 MONTHS AGO AT A (B)(6) CENTER. PER THE MAUDE REPORT, THE PT MET WITH THE AUTHORIZED REP OF THE DOCTOR AND SIGNED THE ARBITRATION AGREEMENT WITH THE CENTER. HIS EYES AND VISION WERE EVALUATED AND THE VISION WITHOUT GLASSES BASICALLY 20/20. READING VISION WITHOUT GLASSES 20/50 & 20/80. PUPIL SIZES: 10 MM & 12/23 MM. ON AN UNK DATE IN 2010. HIS LASIK SURGERY DONE. LASIK PERFORMED BETWEEN 2:42 - 2:58 PM. MONOVISION WAS THE OBJECTIVE - IS THIS CORRECT - NO DOMINANT EYE TEST WAS PERFORMED. NO DISCUSSION ABOUT WHY LASIK DONE ON BOTH EYES FOR "MONOVISION". READING EYE OS. ON AN UNK DATE IN 2009 BOTH EYES BLURRY. ON AN UNK DATE IN 2009 OS BLURRY AND 20/40 VA DISTANCE. ON AN UNK DATE IN 2009 OS 20/30-2 VA DISTANCE. ON AN UNK DATE IN 2009 OS CONTACT LENS, OS 20/30-2 VA DISTANCE. ON AN UNK DATE IN 2009 OS FEELS SWOLLEN; OU BLURRY. OD BLURRY 20/80 NEAR VA ON AN UNK DATE IN 2009, NO COMMENTS. ON AN UNK DATE IN 2009, NEEDS CONTACT LENSES, SEES OKAY WITH CONTACT LENSES, "EXCELLENT" ACCORDING TO RECORD. ON AN UNK DATE IN 2009, RESTASIS PRESCRIBED FOR DRY EYE. ON AN UNK DATE IN 2009 NO COMMENTS. ON AN UNK DATE IN 2010 INTERMITTENT DOUBLE VISION, EYES DRY AND SORE. GLASSES DO NOT IMPROVE VISION. RESTASIS PRESCRIBED FOR 4 WEEKS. ON AN UNK DATE IN 2010, THE PT CALLED CLINIC REGARDING DRY EYES. HE TOLD CLINIC FOLKS THAT NEITHER THE CONTACT LENSES NOR THE RESTASIS AFFECTED TREATED HIS DRY EYES. ON (B)(6) 2010, COMMENTS FROM RECORDS NOT LEGIBLE. ON (B)(6) 2010, COMMENTS ON RECORDS NOT LEGIBLE. PT SAYS, HE CALLED THE DOCTOR AND VISITED HER OFFICE REPORTED FOR MANY COMPLAINING OF EXTREMELY DRY EYES, EXTREME PAIN AND DISCOMFORT REQUIRING LARGE DOSES OF IBUPROFEN. LOSS OF NIGHT AND LOW LIGHT VISION WITH STARBURSTS. EXTREME PHOTOPHOBIA, DOUBLE VISION, BLURRED VISION, LACRISERT, RESTASIS, CONTACT LENSES. HE IS CURRENTLY SEEING A DOCTOR WHO PERMANENTLY BLOCKED BOTH LOWER AND UPPER DUCTS AND PRESCRIBED NUMEROUS OINTMENTS AND EYE DROPS BUT NOTHING IS WORKING VERY WELL. SURGERY IS BEING PLANNED ON HIS EYELIDS TO REDUCE TEAR EVAPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX EXCIMER LASER LZS AMO MANUFACTURING USA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other