BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND CONTACT LENSES

    MDR report key: 2100692 · Received May 18, 2011

    Report

    Report Number
    1033553-2011-00033
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    August 18, 2009
    Report Date
    May 18, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    OUR FIRM REC'D A SUMMONS FROM AN ATTORNEY ON (B)(6) 2011 ALLEGING THAT A PT (B)(6) DEVELOPED AN INJURY IN THE LEFT EYE WHILE WEARING ACUVUE OASYS CONTACT LENSES. THE SUMMONS STATES THAT IN (B)(6) 2009, THE PT REC'D A 6 MONTH SUPPLY OF ACUVUE OASYS CONTACT LENSES. "ON OR ABOUT (B)(6) 2009, (THE PT) OPENED A NEW CONTACT LENS (CL) CONTAINER AND AFTER APPROPRIATELY WASHING (HIS/HER) HANDS AND TAKING PROPER SANITATION PROCEDURES, PLACED THE CONTACT IN (HIS/HER) LEFT EYE." "AFTER 2-3 HOURS OF WEARING THE CONTACT, (THE PT'S) EYE BECAME VERY IRRITATED AND (HE/SHE) TOOK THE CONTACT LENSES OUT AND LAID DOWN TO REST." "WHEN (HE/SHE) WOKE UP, (HIS/HER) EYE WAS SORE AND WATERING. (THE PT) THOUGHT (HE/SHE) HAD SIMPLY IRRITATED (HIS/HER) EYE AND LEFT THE CL OUT." "THE NEXT DAY WHEN (HE/SHE) AWOKE, BOTH EYES WERE SENSITIVE AND PHOTOPHOBIC AND (HIS/HER) LEFT EYE WAS SWOLLEN AND HAD SPOTS IN IT." "(THE PT) SOUGHT MEDICAL TREATMENT FROM A DOCTOR, AND THEN SOUGHT TREATMENT FROM ANOTHER DOCTOR IN (B)(6). THE SECOND DOCTOR "CULTURED THE CL CONTAINER AND DETERMINED THAT IT WAS DEFECTIVE AND THAT IT CONTAINED BACTERIA." THE SAME DOCTOR "FURTHER CULTURED THE (PT'S) LEFT EYE AND DETERMINED THAT IT CONTAINED THE SAME BACTERIA. "THE BACTERIA DESTROYED (THE PT'S) CORNEA IN (HIS/HER) LEFT EYE." "A CORNEA TRANSPLANT WAS ATTEMPTED AND WAS NOT SUCCESSFUL." "AS A RESULT OF THE BACTERIA AND SEQUELAE, (THE PT) ALSO DEVELOPED GLAUCOMA AND CATARACTS." "AS A RESULT OF (HIS/HER) LOSS OF SIGHT, KNOCKS INTO ITEMS CAUSING (HIS/HER) ADDITIONAL INJURIES." ADDITIONAL INFORMATION, INCLUDING PRODUCT AND THE PRODUCT LOT NUMBER HAS BEEN REQUESTED, BUT HAS NOT BEEN REC'D. IF ADDITIONAL INFORMATION IS REC'D, WE WILL REPORT IT WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS BRAND CONTACT LENSES SOFT CONTACT LENS LPM VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| S