BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREVISION (BALAFILCON A) CONTACT LENS

    MDR report key: 1900007 · Received November 9, 2010

    Report

    Report Number
    1313525-2010-00024
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    LPM
    PMA / PMN Number
    P980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTACT LENS INVOLVED IN THE EVENT WAS DISCARDED BY THE HOSPITAL. THE LOT DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED AND SHOW THAT ALL REQUIREMENTS WERE MET. THE REPORTING OPTICIAN INDICATED THE LENS WAS NOT THE CAUSE OF THE EVENT. THE PT WAS POKED IN THE EYE WITH A CHILD'S FINGER. BASED ON ALL INFO, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    OPTICIAN REPORTED A PT WAS DIAGNOSED WITH CORNEAL EROSION AND INDICATED THAT THE PT WAS POKED IN THE EYE WITH A CHILD'S FINGER. PT VISITED AN EYE DOCTOR WHO PRESCRIBED THE PUREVISION LENS AS A THERAPY LENS. PT THEN VISITED OPTICIAN WHO DISPENSED AND FITTED THE LENS ON THE PATIENT'S EYE. LATER THAT EVENING, PATIENT'S EYE WORSENED AND WENT TO A HOSPITAL AND WAS DISCHARGED ONE WEEK LATER. DETAILS RELATED TO THE HOSPITAL VISIT SUCH AS TREATMENT WERE NOT PROVIDED. OPTICIAN HAS CONFIRMED THE PATIENT'S EYE CONDITION HAS STABILIZED WITH SOME REDNESS PRESENT. THE OPTICIAN AND THE PT CONSIDER THE MATTER CLOSED. OPTICIAN STATED THAT THE EVENT WAS NOT RELATED TO THE LENS, HOWEVER, IT IS UNKNOWN IF THE LENS MAY HAVE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUREVISION (BALAFILCON A) CONTACT LENS LPM BAUSCH + LOMB R08507611

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R