BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS WITH HYDRACLEAR

    MDR report key: 1130864 · Received August 20, 2008

    Report

    Report Number
    1033553-2008-00097
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    March 7, 2008
    Report Date
    August 20, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ON 7/28/08, A PT INFORMED US THAT HE/SHE DEVELOPED IRITIS OD EARLIER THIS YEAR. THE PT HAD BEEN WEARING ACUVUE OASYS CONTACT LENSES (CL) FOR A YEAR, WEARING ON A DAILY WEAR SCHEDULE AND REPLACING THEM ON A MONTHLY BASIS. THE PT WAS USING PEROXIDE BASED CLEANING SYSTEM. THE PT STATED THAT INITIAL SYMPTOMS WERE EYE REDNESS, PAIN TO TOUCH AND BLURRY VISION. IN 2008, THE PT SAW AND RECEIVED INITIAL TREATMENT FROM AN OPHTHALMOLOGIST WHO PRESCRIBED STEROIDS EVERY 4 HOURS. THE PT HAD FOLLOW-UP VISITS IN THE SAME MONTH, AND THE FOLLOWING MONTH, WAS ALLOWED TO RESTART WEARING CL. THE PT DID NOT REMEMBER THE NAME OF THE TREATING OPHTHALMOLOGIST. NINE DAYS LATER, THE PT HAD A YEARLY EYE EXAM BY THE PT'S REGULAR EYE CARE PROFESSIONAL (ECP). THE PT RETURNED TO THE ECP TWO MONTHS LATER, COMPLAINING OF A DECREASE IN VISUAL ACUITY OD AND WAS DIAGNOSED WITH IRITIS. THE ECP PRESCRIBED PRED FORTE EVERY HOUR, THEN EVERY 4 HOURS, WITH CONTINUED TITRATION AND DISCONTINUED THE FOLLOWING MONTH. THE ECP STATED THAT THE IRITIS WAS IDIOPATHIC IN NATURE AN SUGGESTED THAT RECURRENCE COULD BE BECAUSE THE PT WAS NOT HEAVILY TREATED WITH STEROIDS DURING THE INITIAL EVENT, WHICH MADE THE PT MORE SUSCEPTIBLE TO RECURRENCE. THE PT'S BCVA WAS 20/20 PRIOR TO THE EVENT, 20/30 AT WORST DURING THE EVENT AND 20/20 AFTER THE EVENT. A DEVICE HISTORY WAS PERFORMED. THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. A PRODUCT EVAL WAS PERFORMED ON LENSES FROM THE SAME LOT. THE PARAMETERS OF THE LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS AND DIAMETER. NO VISUAL ATTRIBUTES WERE OBSERVED. THE SOLUTION WAS ALSO TESTED. THE PH AND CONDUCTIVITY WERE WITHIN SPECIFICATION. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS. ANY ADD'L INFO WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS WITH HYDRACLEAR SOFT CONTACT LENS LPL VISTAKON B006QSR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R