BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 BRAND CONTACT LENS

    MDR report key: 4081114 · Received August 29, 2014

    Report

    Report Number
    1033553-2014-00073
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    January 1, 1999
    Report Date
    August 29, 2014
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING: SINGLE USE OR REUSE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CALL WAS REC'D FROM A PATIENT (PT) REPORTING A CORNEAL ULCER IN 1999 WHILE WEARING ACUVUE 2 BRAND CONTACT LENSES. THE PT WAS LIVING IN (B)(6) AT THE TIME OF THE EVENT. THE PT STATED THAT SHE WAS "SLEEPING IN THE LENSES BACK THEN AND CHANGING WHEN THEY FELL APART." SHE STATES THAT HER EYE (AFFECTED EYE UNKNOWN) BECAME SO PAINFUL THAT HE/SHE PRESENTED TO THE EYE CARE PROFESSIONAL (ECP) AND WAS DIAGNOSED WITH A CORNEAL ULCER. THE PT ADVISED THAT HE/SHE WAS TREATED WITH AN EYE OINTMENT TID, AN EYE DROP TID, AND DISCONTINUED FROM CONTACT LENS (CL) WEAR FOR 1 WEEK. THE PT ADVISED THAT HE/SHE RETURNED TO THE ECP AFTER 1 WEEK AND STATES THAT THE EXP DISCONTINUED THE MEDICATIONS AT THAT VISIT. THE PT RETURNED TO THE ECP FOR F/U AT THE END OF WEEK 2 AND STATED THAT THE EXP ADVISED THAT THE CORNEAL ULCER HAD HEALED. THE PT ADVISED THAT THE ECP STATED THAT HE/SHE COULD RETURN TO CL WEAR. THE PT STATES THAT HE/SHE WAS RETURNED TO ACUVUE 2 LENSES AT THAT VISIT. THE PT ADVISED THAT THE LENS "STILL FELT A LITTLE SCRATCHY, SO I REMOVED THE LENS AND DIDN'T RETURN TO CL'S WEAR FOR ANOTHER 2 WEEKS." THE PT ADVISED THAT AFTER 4 WEEKS OF NO CL WEAR, HE/SHE RETURNED TO CL WEAR WITHOUT THE RETURN OF SYMPTOMS. THE SUSPECT CL AND LOT NUMBER WERE DISCARDED SINCE THIS EVENT OCCURRED IN 1999. THE PT STATES THAT HE/SHE THOUGHT THE CURRENT ECP HAD THE MEDICAL RECORDS FROM THE 1999 CORNEAL ULCER. A CALL WAS PLACED TO THE PATIENT'S CURRENT ECP IN HOPES TO OBTAIN ADD'L INFO, BUT THE ECP REPORTED THAT HE/SHE DIDN'T HAVE THE PATIENT'S PAST MEDICAL RECORDS. THE CURRENT PRESCRIBING ECP STATED ON THE PATIENT'S LAST EXAM ON (B)(6) 2014, HE/SHE NOTED THAT A "SCAR WAS PERIPHERAL AND TINY IN THE PATIENT'S OD." NO ADD'L INFO IS EXPECTED. NO LOT NUMBER WAS AVAILABLE, THEREFORE, NO DEVICE HISTORY REVIEW CAN BE CONDUCTED. BASED ON ALL AVAILABLE INFO, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN. ANY ADD'L INFO REC'D WILL BE REPORTED WITHIN 20 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527662 ACUVUE 2 BRAND CONTACT LENS SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention