BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND WITH HYDRACLEAR PLUS

    MDR report key: 1401368 · Received June 8, 2009

    Report

    Report Number
    1033553-2009-00035
    Event Type
    Injury
    Date Received
    June 8, 2009
    Date of Event
    September 15, 2008
    Report Date
    June 8, 2009
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LABELED FOR SINGLE USE AND REUSE. DEVICE DISCARDED: UNABLE TO FOLLOW-UP. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    PT CALLED OUR FIRM AND REPORTED DEVELOPING A CORNEAL ULCER. THE PT SAID HE WAS WORKING ON A SPORT FISHING BOAT AT THE TIME. THE PT SAID HIS EYE IS FINE AT THIS TIME. REQUESTED THE PT CONTACT HIS ECP'S OFFICE TO RELEASE INFORMATION. RECEIVED MEDICAL RECORD FROM ECP'S OFFICE. THE RECORD STATES THE PT WAS SEEN IN 2009, THE PT WOKE UP WITH PAIN AND PHOTOPHOBIA, THE LENS WAS REMOVED THE PREVIOUS NIGHT. THE PT WAS USING VISINE WITHOUT RELIEF. THE PT'S EYES WERE RED, AND WATERY. THE ECP NOTED THE PT HAD A ROUND, WHIT SPOT, MID-PERIPHERAL OS WITH FLUORSCEIN STAINING AND + CELL IN THE ANTERIOR CHAMBER. THE PT WAS PRESCRIBED VIGAMOX, ZYMAR AND CYCLOPENTOLATE. THE PT RETURNED TO THE OFFICE IN THE NEXT DAY, REPORTED SYMPTOMS SOMEWHAT BETTER. THE PT HAD 2+ INJECTION, NO EDEMA, +NAFL STAIN, ANTERIOR CHAMBER QUIET. THE ULCER HAD A FEATHERY BORDER. VA OS WITHOUT CORRECTION 20/60. MEDS: TOBRADEX UNG QHS, CYCLOPENTOLATE TID. AT ABOUT 2 DAYS LATER, PT RETURNED TO CLINIC. PT STILL SENSITIVE TO LIGHT OS. ECP NOTED "DEFINED EPITHELIAL DEFECT. +FLUORSCEIN STAINING, INFILTRATE." ASSESSMENT: IMPROVING PERIPHERAL ULCER. PLAN: CONTINUE MEDS. IN THE NEXT DAY, THE PT REPORTS DOING BETTER, NO PAIN, FEELS SCRATCHY, BLURRY VISION. VA OS WITHOUT CORRECTION, 20/60. THE ECP NOTES THERE IS A SMALL AREA OF STAIN IN THE FILTRATE, NO SWELLING AND ANTERIOR CHAMBER DEEP AND QUIET. A 2+ INJECTION, NO EDEMA. ASSESSMENT: RESOLVING CORNEAL ULCER. CONTINUE TOBRADEX UNG QHS AND CYCLOPENTOLATE, ZYMAR Q2H. AT ABOUT 3 DAYS LATER, PT SAID DOING BETTER. NO STAINING OS, PT HAS INFILTRATE AT SITE OF ULCER. ASSESSMENT: RESOLVING ULCER, INFILTRATE REMAINS. MEDS: CYCLOPENTOLATE BID, TOBRADEX UNG QHS, ZYMAR QID. THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT 4 DAYS LATER; THE PATIENT DID NOT SHOW FOR THAT APPOINTMENT. THE PT DID NOT RETURN TO THE OFFICE FOR ANY FURTHER CARE. NO ADDITIONAL INFORMATION IS EXPECTED. THE LENS IN QUESTION WAS DISCARDED. THE PT HAD NO REMAINING PRODUCT FROM THAT LOT; THE LOT NUMBER WAS PROVIDED. A LOT HISTORY REVIEW REVEALED THE FOLLOWING: 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. MDR EVENTS ARE REVIEWED AT QUARTERLY MANAGEMENT REVIEW MEETINGS. NO ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS BRAND WITH HYDRACLEAR PLUS SOFT CONTACT LENSES LPL VISTAKON NA B006B78

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention