BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMEDICS EP

    MDR report key: 1397153 · Received June 1, 2009

    Report

    Report Number
    1118577-2009-00001
    Event Type
    Injury
    Date Received
    June 1, 2009
    Date of Event
    July 16, 2008
    Report Date
    April 20, 2009
    Manufacturer
    COOPERVISION INC.
    Product Code
    LPL
    PMA / PMN Number
    K061948
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE LOT HISTORY WAS REVIEWED. THE LOT WAS MANUFACTURED ACCORDING TO APPROVED SOPS, BASE CURVE, DIAMETER, OSMOLARITY/PH AND VISUAL INSPECTION TESTS ALL PASSED. SURFACE WAS GOOD AND ALL MEASUREMENTS WERE WITHIN MANUFACTURING SPECIFICATIONS. THE LOT MET ALL FINAL RELEASE CRITERIA FOR PARAMETERS, QUALITY, STERILITY AND PACKAGING. A 12-MONTH REVIEW OF THE COMPLAINT HISTORY FOR THE DEVICE TYPE FINDS NO OTHER COMPLAINTS OF CORNEAL ULCER (MK). THERE ARE NO REMAINING LENSES IN THE LOT AVAILABLE FOR INSPECTION AND THE ACTUAL LENS WAS NOT RETURNED FOR EVALUATION. THIS IS THE ONLY COMPLAINT THAT HAS BEEN RECEIVED TO DATE, OF ANY NATURE, FOR THIS LOT OF LENSES. THE INVESTIGATION FINDS NO CAUSAL RELATIONSHIP BETWEEN THE LENS AND THE INCIDENT. THE PATIENT HAD BEEN USING THE LENS AS DIRECTED FOR 6 TO 8 MONTHS PRIOR TO THE ONSET OF THE INCIDENT. IN ADDITION, THE ECP HAS REPORTED THAT DURING A PERIOD OF TIME SURROUNDING THIS INCIDENT, 4 OTHER PATIENTS SUFFERED CORNEAL ULCERS WEARING A LENS FROM ANOTHER CONTACT LENS MANUFACTURER AND USING THE SAME CLEANING SOLUTION. THIS FURTHER SUPPORTS THE CONCLUSION THAT NO DIRECT CAUSAL RELATIONSHIP EXISTS BETWEEN THIS LENS AND THE INCIDENT. THIS IS BEING REPORTED AS A CORNEAL ULCER WITH PERMANENT SCARRING AND REDUCTION OF BEST CORRECTED VISUAL ACUITY (20/20 TO 20/40) WITH NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE USE OF THE LENS AND THE INCIDENT.

    Description of Event or Problem · 1

    ECP PROVIDES PATIENT WITH TRIAL UNITS OF BIOMEDICS EP SOFT CONTACT LENS FOR DAILY WEAR IN APPROXIMATELY 2008. IN 2009, PATIENT PRESENTED WITH CORNEAL ULCER (MK) IN LEFT EYE. ECP STATED "SEVERE CORNEAL ULCER CENTER OF VISION. APPROXIMATELY 10MM IN SIZE WHICH LEFT A 5MM SCAR." PATIENT WAS TREATED BY ECP AND BY AN UNKNOWN SPECIALIST FOR SUSPECTED MICROBIAL INFECTION. INITIALLY, INFECTION WAS RESISTANT TO ANTIBIOTICS, BUT DID EVENTUALLY RESPOND. PRESCRIBED MEDICATION NAME(S) AND/OR TREATMENT(S) WAS NOT PROVIDED. PATIENT HAS SCARRING OVER 15% OF CENTRAL CORNEAL AREA AND CORNEA NEARLY PERFORATED. PERMANENT LOSS OF VISUAL ACUITY - BEFORE 20/20 - AFTER 20/40. ECP HAS ADVISED PATIENT TO PERMANENTLY DISCONTINUED CONTACT LENS WEAR. RIGHT EYE IS NOT INVOLVED IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMEDICS EP OMAFILCON A MULTIFOCAL SOFT CONTACTLENS LPL COOPERVISION INC. 200794871D

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability SOLUTION| DISINFECTION REGIMEN: COMPLETE MULTIPURPOSE