BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUVUE OASYS

    MDR report key: 1062675 · Received May 20, 2008

    Report

    Report Number
    1033553-2008-00059
    Event Type
    Other
    Date Received
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    p040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT ALLEGES THAT AFTER A WEEK OF USE OF AVO, PT'S RIGHT EYE "STARTS TO ITCH, HAVE CONSTANT SECRETIONS AND SWELLING". PT ALLEGES ALLERGIC RESPONSE. F/U WITH PT REVEALS THAT AFTER 4-5 DAYS OF LENS WEAR, THE PT EXPERIENCES DISCHARGE AND REDNESS. SYMPTOMS RESOLVE WITH REMOVAL OF THE LENSES. THE PT DID NOT CONSULT AN EYE CARE PROVIDER. PT IS USING OPTIFREE REPLENISH FOR STORAGE AND DISINFECTION AND USING OVER THE COUNTER DROPS FOR SELF TREATMENT. PROD WAS NOT RETURNED AND NO LOT INFO WAS PROVIDED. NO EVAL CAN BE CONDUCTED AND NO CONCLUSION CAN BE DRAWN. THE PT DID NOT F/U WITH A PHYSICIAN OR OTHER MEDICAL PROFESSIONAL. THE REPORTED SYMPTOMS RESOLVED WITH REMOVAL OF LENSES FROM THE EYE. SYMPTOMS OCCURRED AFTER SEVERAL DAYS OF WEAR AND RESOLVE WITH REMOVAL OF THE LENSES. OTHER FACTORS MAY INCLUDE BUT ARE NOT LIMITED TO: LENS CARE, LENS CARE SOLUTION, ENVIRONMENTAL FACTORS, AND GENERAL OCULAR HEALTH. NO CONCLUSION CAN BE DRAWN REGARDING CAUSAL ROLE OF THE CONTACT LENS ALONE. THE EVENT REPORTED DOES NOT WARRANT REMEDIAL ACTION. NO REMEDIAL ACTION IS PLANNED. THE CUSTOMER HAS DISCARDED THE LENS IN QUESTION. PROD WAS NOT RETURNED AND NO LOT INFO WAS PROVIDED. NO EVAL CAN BE CONDUCTED AND NO CONCLUSION CAN BE DRAWN. NO PROD WAS AVAILABLE FOR EVAL. NO CONCLUSION CAN BE DRAWN. NO PERMANENT INJURY WAS INCURRED BY THE PT AND NO TREATMENT WAS REQUIRED TO PREVENT SUCH OCCURRENCE. OTHER VARIABLES SUCH AS LENS CARE OR OTHER ENVIRONMENTAL FACTORS MAY OR MAY NOT HAVE FACTORED IN THE REPORTED EVENT. THEREFORE, THIS EVENT IS NOT INCLUDED IN ANY TREND ANALYSIS AND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED THROUGH THE MDR PROCESS. IF ADD'L INFO IS REC'D, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MGMT REVIEW MEETINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other