BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX, STAR S4 CUSTOMVUE WAVEFRONT-GUID

    MDR report key: 1870649 · Received October 7, 2010

    Report

    Report Number
    MW5017719
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    May 6, 2009
    Report Date
    October 7, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) WAS INJURED BY LASIK ABOUT 17 MONTHS AGO AT THE LASIK CENTER (B)(6). (B)(6), MD WAS THE LASIK SURGEON. BECAUSE OF HIS SEVERE VISION DISABILITY, HE ASKED ME TO SUBMIT THIS MEDICAL DEVICE REPORT TO FDA. AS FAR AS HE IS AWARE, THE USER FACILITY HAS NOT SUBMITTED A MDR REPORT. HE MET WITH (B)(6) THE AUTHORIZED REPRESENTATIVE OF (B)(6) MD. SIGNED THE ARBITRATION AGREEMENT WITH THE CENTER. HIS EYES AND VISION WERE EVALUATED AT 11:44 AM, AND VISION WITHOUT GLASSES BASICALLY 20/20. READING VISION WITHOUT GLASSES 20/50 AND 20/80. PUPIL SIZES: 10MM AND 12/23MM. ON (B)(6) 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 (B)(6) 2009, BOTH EYES BLURRY. ON (B)(6) 2009, OS BLURRY AND 20/40 VA DISTANCE. ON (B)(6) 2009, OS 20/30-2 VA DISTANCE. ON (B)(6) 2009, OS CONTACT LENS, OS 20/30-2 VA DISTANCE. ON (B)(6) 2009, OS FEELS SWOLLEN; OU BLURRY; OD 20/80 NEAR VA. ON (B)(6) 2009, NO COMMENTS. ON (B)(6) 2009, NEEDS CONTACT LENSES. SEES OKAY WITH CONTACT LENSES. "EXCELLENT" ACCORDING TO RECORD. ON "(B)(6) 2009", RESTASIS PRESCRIBED FOR DRY EYE. ON (B)(6) 2009, NO COMMENTS. ON (B)(6) 2010, INTERMITTENT DOUBLE VISION. EYES DRY AND SORE. GLASSES DO NOT IMPROVE VISION. RESTASIS PRESCRIBED FOR 4 WEEKS. ON (B)(6) 2010, MR (B)(6) CALLED THE CLINIC REGARDING DRY EYES. HE TOLD CLINIC FOLKS THAT NEITHER THE CONTACT LENSES NOR THE RESTASIS AFFECTED TREATED HIS DRY EYES. ON 04/01/2010, COMMENTS FROM RECORDS NOT LEGIBLE. ON 04/11/2010, COMMENTS FROM RECORDS NOT LEGIBLE. MR (B)(6) SAYS HE CALLED DR (B)(6) AND VISITED HER OFFICE REPEATED FOR MANY COMPLAINING OF EXTREMELY DRY EYES, EXTREME EYE 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 DR (B)(6) 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. DIAGNOSIS OR REASON FOR USE: MONOVISION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO. SUSPECT PRODUCT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX, STAR S4 CUSTOMVUE WAVEFRONT-GUID LASIK LZS ABBOTT MEDICAL OPTICS WAVEFRONT WAVESCAN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention