BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND CONTACT LENSES

    MDR report key: 3962594 · Received July 14, 2014

    Report

    Report Number
    1033553-2014-00052
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 14, 2014
    Manufacturer
    LIMERICK IRELAND
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW 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. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY FRANCHISE MANAGEMENT REVIEW MEETINGS. DEVICE LABELING SINGLE USE OR REUSE; DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED, UNABLE TO CONFIRM COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A PATIENT (PT) CONTACTED OUR FIRM REPORTING HAVING EXPERIENCED AN OCULAR EVENT OD WHILE WEARING ACUVUE OASYS CONTACT LENSES (CL). THE PATIENT WAS WEARING LENSES ON A DAILY WEAR SCHEDULE FOR 14 HRS A DAY AND PRIOR TO THAT TIME, THE PT WORE FOR 16-18 HRS BECAUSE THE PT WAS IN SCHOOL. THE PT REPLACED LENSES EVERY 2-3 WEEKS AND USED OPTI FREE LENS CARE SOLUTION. (B)(6) 2014 THE PT STARTED USING LENSES FROM A NEW BOX AND EXPERIENCING OD LIGHT SENSITIVITY, ITCHING, REDNESS THINKING IT WAS RELATED TO ALLERGIES. THE PT CHANGED TO A NEW PAIR OF LENSES BUT THE SYMPTOMS RECURRED A WEEK LATER. ON (B)(6) 2014 THE TREATING EYE CARE PROFESSIONAL (ECP) STATED THE PT DID NOT HAVE AN INFECTIOUS ISSUE. THE PT WAS DIAGNOSED WITH PANNUS AND CORNEAL NEOVASCULARIZATION, THE ECP HAS NEVER SEEN PANNUS THIS SEVERE BEFORE; VA WAS 20/100. MEDICAL RECORDS WERE RECEIVED INDICATING THE FOLLOWING: THE PT. HAS BEEN WEARING ACUVUE OASYS CONTACT LENSES FOR SEVERAL YEARS AND FOR 12-14 HOURS DAILY, REPLACING THEM EVERY 2-3 WEEKS WITHOUT ANY ISSUES. ON (B)(6) 2014 THE PT. PRESENTED TO ECP C/O OD IRRIGATION, TEARING, ITCHING AND LIGHT SENSITIVITY WHEN WEARING CL PT. DENIED PREVIOUS OCULAR INJURY AND DENIED SLEEPING IN CONTACT LENSES. THE PT REPORTED THE PT HAD BEEN EXPERIENCING "SEVERE BURNING", BLURRY VISION, MILD ITCHING, REDNESS, TEARING, AND SENSITIVITY TO LIGHT IN OD. PT. ALSO REPORTED EXPERIENCING CONSISTENT, TOLERABLE HEADACHE, MAINLY AROUND EYE AREA AND OD PAIN AND STRAIN WHEN DRIVING. SLIT LAMP EVALUATION OF OD REVEALED SEVERE SUPERIOR CORNEAL NEOVASCULARIZATION, MILD STAINING SECONDARY TO CL WEAR, (+) MILD FL STAINING OF PANNUS/CORNEAL NEO, GR 3+/4. SCREENING OF THE OD ANTERIOR SEGMENT USING WHITE LIGHT IMAGING REVEALED GR 4 CORNEAL NEOVASCULARIZATION. THE PT WAS TREATED WITH LOTEPREDNOL 1 DROP TID X2 WEEKS AND INSTRUCTED TO FOLLOW UP IN 1 WEEK. BCVA DISTANCE VISION WITH WEARING A PAIR OF "OLD GLASSES" WAS 20/100. ON (B)(6) 2014 THE ECP'S OFFICE CALLED TO CHECK ON THE PT WHO REPORTED THE EYE WAS STILL "IRRITATED AND SORE, BUT SEEMS TO BE SLIGHTLY GETTING BETTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409073 ACUVUE OASYS BRAND CONTACT LENSES DISPOSABLE SOFT CONTACT LENS LPL LIMERICK IRELAND NA L00231S

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R OPTI-FREE LENS CARE SOLN