BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION

    MDR report key: 1162143 · Received September 2, 2008

    Report

    Report Number
    1061857-2008-00181
    Event Type
    Injury
    Date Received
    September 2, 2008
    Date of Event
    January 1, 2007
    Report Date
    August 26, 2008
    Manufacturer
    ALCON -ORLANDO TECHNOLOGY CENTER
    Product Code
    LZS
    PMA / PMN Number
    P970043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DETERMINATION OF ROOT CAUSE: ASSESSMENT; A THOROUGH COMPLAINT INVESTIGATION COULD NOT BE PERFORMED FOR THIS ALLEGED EVENT BECAUSE THE EVENT WAS REPORTED TO ALCON VIA A MEDWATCH FORM SUPPLIED BY THE FDA THAT DID NOT CONTAIN ANY PROD SPECIFIC INFO, ANY RPTR/PT CONTACT INFO, ANY TREATING FACILITY INFO OR ANY ATTENDING PHYSICIAN/SURGEON CONTACT INFO. NON-PROD FACTORS INCLUDING PT RESPONSE TO THE LASER ABLATION, PT HEALING CHARACTERISTICS AND PREOPERATIVE PT SELECTION COULD NOT BE REVIEWED BECAUSE NO PT SPECIFIC INFO (PT CLINICAL RECORDS) WERE AVAILABLE. CONCLUSION: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE LACK OF INFO PROVIDED.

    Description of Event or Problem · 1

    REC'D A VOLUNTARY MEDWATCH REPORT FROM THE FDA. THE RPTR/PT INDICATED EXPERIENCING VISUAL DIFFICULTIES FOLLOWING BILATERAL CUSTOM REFRACTIVE SURGERY FOR MYOPIA. THIS REPORT IS FOR THE LEFT EYE, THE RIGHT EYE IS BEING REPORTED UNDER MFR REPORT # 1061857-2008-00182. FOLLOWING SURGERY, THE PT REPORTED LARGE STARBURSTING AND HALOS UNDER LOW LIGHT CONDITIONS; REDUCED LOW LIGHT CONTRAST SENSITIVITY; DIFFICULTY DRIVING AT NIGHT; CORNEAL IRREGULARITIES; CENTRAL ISLANDS. HIGH INCREASE IN FLOATERS; AND POSTERIOR VITREOUS DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION OPHTHALMIC EXCIMER LASER LZS ALCON -ORLANDO TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other