BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS FOR PRESBYOPIA

    MDR report key: 2651255 · Received February 19, 2010

    Report

    Report Number
    1033553-2010-00173
    Event Type
    Injury
    Date Received
    February 19, 2010
    Date of Event
    February 2, 2010
    Report Date
    February 19, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIVE SEALED BLISTERS WERE RETURNED. THE PARAMETERS OF THE LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MET COMPANY STANDARDS FOR DIAMETER, BASE CURVE AND CENTER THICKNESS. NO VISUAL ATTRIBUTES WERE OBSERVED ON ANY LENSES. THE RETURNED SOLUTION WAS TESTED. THE PH AND CONDUCTIVITY WERE WITHIN SPECIFICATION. THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATIONS. IF ADD'L INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS. DEVICE LABELING SINGLE USE OR REUSE.

    Description of Event or Problem · 1

    EYE CARE PROVIDER CALLED OUR FIRM TO REPORT PT WITH INFECTIOUS KERATITIS. TREATMENT RECORDS WERE PROVIDED. SUMMARY AS FOLLOW: (B)(6) 2010, PT PRESENTED WITH "EYE RED AND PAINFUL" OS, YESTERDAY, WORSE IN SUN. CL LAST WORN YESTERDAY. VA'S OD 20/25 OS 20/40. IMP: K ABRASION WITH MILD INFLAMMATION OS. D/C LENS WEAR. TX: VIGAMOX QID X 5 DAYS; WAIT 2 DAYS BEFORE INSERT CL. ON (B)(6) 2010, CC: "VISION BLURRED AND MORE UNCOMFORTABLE..." EPI DEFECT DX'D TUESDAY. IMP: INFECTIOUS KERATITIS OS-CYCLOPLEGED. INCREASE ANTIBIOTIC TO Q15 MINS X 1 HR, THEN Q 30 MINS X 6 HOURS, THEN Q1H TIL F/U DIAGRAM SHOWS "SMALL EPI DEFECT WITH SEI" NEAR CENTRAL, FOLDS IN DESCEMENT'S. ON (B)(6) 2010 CC: "BLURRINESS AND SORENESS (PRESSURE) IS BACK" MED ZYMAR Q1H. IN OFFICE CYCLOPLEGED AND RX CYCLOPENTOLATE BID; CONTINUE ZYMAR Q1H; AT'S 4-5 X /DAY. DIAGRAM SHOWS 0.5 MM EPI DEFECT W/INFILTRATE. BOWMAN'S/ANT STROMA. NO FOLDS IN DESCEMENT'S. ON (B)(6) 2010 CC: "FEELING BETTER AND LESS CLOUDY" CONTINUE CYCLOPLEGED BID, TAPER ZYMAR TO Q3H TILL F/U: START PF 1% Q3H. DIAGRAM: SEI W/O EPI DEFECT AND W/O FOLDS IN DESCEMENT'S. ON (B)(6) 2010 IMP: INFECTIOUS KERATITIS OS -IMPROVING; TAPER CYCLOPENTOLATE TO GAM; PF/ZYMAR Q3H TODAY THEN TAPER TO QID TOMORROW TIL FRIDAY. DIAGRAM: <0.5 MM SEI WITHOUT DESCEMET'S FOLDS; FEW SPK. ON (B)(6) 2010 CC: REPORTS, "EVEN BETTER" -CYCLOPENTOLATE QAM TODAY, TOMORROW, THEN D/C; CONT PF/ZYMAR QID; F/U TUES. ON (B)(6) 2010 CC: RTC 4 DAYS RE: RESOLVING KERATITIS; REPORTS "EVEN BETTER..." IMP: RESOLVING INFILTRATE OS -CONT PF/ZYMAR QID THRU EDS: TID THURS, BID FRI QAM SAT; D/C SUN. NO CL'S TIL TUES-WEDS. DIAGRAM: "RESOLVING INFILTRATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS FOR PRESBYOPIA SOFT CONTACT LENS LPM VISTAKON NA B007RXJ

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R