BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY COMFILCON A) (SPHERE)

    MDR report key: 1622476 · Received February 26, 2010

    Report

    Report Number
    9614392-2010-00003
    Event Type
    Injury
    Date Received
    February 26, 2010
    Date of Event
    January 12, 2010
    Report Date
    February 3, 2010
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPL
    PMA / PMN Number
    K052560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: AN INVESTIGATION INTO THIS MATTER IS ONGOING. A REVIEW OF THE COMPLAINTS HISTORY FOR THIS DEVICE WAS PERFORMED AND FOUND NO OTHER COMPLAINTS IN THE LAST 24 MONTHS INVOLVING A MICROBIAL KERATITIS OF THE EYE. THIS IS THE ONLY COMPLAINT OF ANY TYPE RECEIVED FOR THIS LOT OF LENSES. EVALUATION RESULTS: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT THE PT COMPLAINS OF. EVALUATION CONCLUSION: NO CONCLUSION CAN BE DRAWN. THIS IS BEING REPORTED AS A MICROBIAL KERATITIS OF THE RIGHT EYE WITH NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT. THE (B) (6) OFFICE REPORTS THE PT WAS PARTICIPATING IN A "CLINICAL" BUT WILL NOT DISCLOSE THE DETAILS OF THE CLINICAL. THE CLINICAL IS NOT SPONSORED BY COOPERVISION, INC. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    (B) (6) REPORTED A CONFIRMED CASE OF MICROBIAL KERATITIS IN A PT. PT FELT PAIN IN RIGHT EYE AROUND 6:00 PM. WHEN HE AWOKE THE NEXT MORNING, HE COULD NOT OPEN HIS RIGHT EYE AT ALL. EYE HURT AND WAS RED. VISION BLURRY. EYE WAS LIGHT-SENSITIVE. ECP CONFIRMED 1.0MM CORNEAL ULCER, FAINT 0.7 MM INFILTRATES AND EDEMA. PT WAS PRESCRIBED: VIGAMOX, POLYTRIM, HOMOTROPINE AND ALREX. LENS WEAR WAS TEMPORARILY DISCONTINUED FROM (B) (6) 2010 TO (B) (6) 2010. (B) (6) CONFIRMS THERE REMAINS AN 0.5MM TRANSLUCENT CORNEAL SCAR ON THE RIGHT EYE LOCATED IN THE SUPERIOR PERIPHERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOFINITY COMFILCON A) (SPHERE) LPL - LENSES, SOFT CONTACT, DAILY WEAR LPL COOPERVISION MANUFACTURING, LTD. 6137560312

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PT WAS PARTICIPATING IN A CLINICAL| THE CLINICAL WAS NOT SPONSORED BY COOPERVISION,INC| (B) (6) STATES SOLUTION BRAND, MFR IS CONFIDENTIAL