BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY (COMFILCON A)

    MDR report key: 2190686 · Received July 26, 2011

    Report

    Report Number
    9614392-2011-00043
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 21, 2011
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. THE LENS WAS RETURNED AND INSPECTED. THE ONLY DEFECT FOUND WAS AN UNIDENTIFIED DEPOSIT ON THE EDGE OF THE OPTICAL ZONE THAT WAS REMOVED WITH GENTLE RUBBING. UNABLE TO ASCERTAIN WHERE THE FOREIGN BODIES ORIGINATED. POSSIBLE CAUSE IS PT HANDLING, BUT DEFINITE ROOT CAUSE COULD NOT BE ESTABLISHED. RESULTS: THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE UNIDENTIFIED FOREIGN BODY, WHICH IS NOT BELIEVED TO BE MFG-RELATED, INDICATES NON-COMPLIANCE TO THE CLEANING REGIME, WHICH MAY BE THE CAUSE OF THE ISSUE. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. NO FAILURE DETECTED AND PRODUCT WITHIN SPEC. THIS IS BEING REPORTED AS A CORNEAL ULCER. WE ARE REPORTING THIS BECAUSE WE CANNOT RULE OUT THAT OUR PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AS REPORTED. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADD'L INFO.

    Description of Event or Problem · 1

    PT WAS FITTED WITH BIOFINITY (COMFILCON A) CONTACT LENSES FROM THEIR EYE CARE PRACTITIONER IN (B)(6). PT REMOVED LENSES FROM THE EYE (B)(6) 2011 AND CAME IN TO EYE CARE PRACTITIONER WITH A VERY RED LEFT EYE AND WAS EXTREMELY PHOTOPHOBIC. RIGHT EYE WAS NORMAL. A CORNEAL ULCER WAS REPORTED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE EYE CARE PRACTITIONER TO OBTAIN ADD'L INFO, BUT THERE HAS BEEN NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOFINITY (COMFILCON A) LPM, SOFT CONTACT LENSES, EXTENDED WEAR LPM COOPERVISION MANUFACTURING, LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other