BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA (ENFILCON A)

    MDR report key: 2041186 · Received March 29, 2011

    Report

    Report Number
    9614392-2011-00011
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    October 1, 2011
    Report Date
    March 2, 2011
    Manufacturer
    COOPERVISION MANUFACTURING, LIMITED
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND OF TWO REPORTS ON THE SAME EVENT INVOLVING TWO LENSES, ONE IS A -8.00 AND THE OTHER IS A -7.50. REFER TO MEDWATCH 9614392-2011-00008 FOR A DESCRIPTION OF THE FIRST REPORT. EVENT WAS REC'D DIRECTLY FROM THE PT VIA E-MAIL TO COOPERVISION'S CUSTOMER SVC DEPT. PT REPORTED AN EYE INFECTION. IT IS UNK WHICH EYE IS INVOLVED IN THE INCIDENT. METHOD: NO LOT INFO, NO LENSES, NO DEVICE INFO, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MED DEVICE AND THE INCIDENT THE PT COMPLAINS OF. CONCLUSION: NO CONCLUSION CAN BE DRAWN. THIS IS BEING REPORTED AS A POSSIBLE EYE INFECTION WITH NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT. 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 WENT TO ECP ON (B)(6) 2010 IN THE USA. PT WAS WEARING J & J ACUVUE LENSES AND PRIOR TO THAT HAD BEEN WEARING B & L SEQUENCE LENSES. PT WAS FIT AND PRESCRIBED AVAIRA CONTACT LENSES. THE PATIENT'S RX IS -8.00 AND -7.50. IN (B)(6), THE PT BEGAN TO SUFFER FROM EYE INFECTIONS. THE PT IS BASED IN ISRAEL AND HER EYE DOCTOR PRESCRIBED REST FROM CONTACTS AND PRESCRIPTION DROPS. ONCE THE PT RETURNED TO LENS WEAR, THE INFECTION RETURNED AND SHE SUFFERED SCARRING ON THE EYE. THE SCARRING DOES NOT AFFECT HER VISION, BUT THE PT HAS BEEN UNABLE TO WEAR LENSES SINCE (B)(6). THE ORIGINAL PRESCRIBING O.D. STATED THAT UPON EXAMINATION ON (B)(6) 2010 HE NOTED THAT THE PT HAD 8 CORNEAL SCARS ON THE RIGHT EYE AND 1 CORNEAL SCAR ON THE LEFT. WHILE THE EVENT DATE OF THE OCCURRENCES IS UNDETERMINED, IT IS CLEAR THAT THE PT WAS NOT WEARING THE COOPERVISION AVAIRA CONTACT LENS PRODUCT DURING THESE INCIDENTS. IN ADDITION, THE ECP HAD NOTED IN THE PATIENT'S FILE THAT THERE WERE NON-COMPLAINT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION MANUFACTURING, LIMITED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention