BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 DEFINE BRAND CONTACT LENSES

    MDR report key: 2855392 · Received November 26, 2012

    Report

    Report Number
    1033553-2012-00066
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    August 17, 2012
    Report Date
    November 25, 2012
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADD'L INFO IS EXPECTED TO BE REC'D. THE LOT NUMBER OF THE PRODUCT IS EXPECTED TO BE REC'D. THE LOT NUMBER OF THE PRODUCT IN QUESTION IS UNK; PRODUCT IS NOT AVAILABLE FOR RETURN FOR EVAL. BASED ON THE LIMITED INFO AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. IF ADD'L INFO IS REC'D, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS. DEVICE LABELING SINGLE USE OR REUSE. DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2012, OUR (B)(4) AFFILIATE REC'D A MEDICAL DEVICE SAFETY INFO REPORT FROM THE (B)(6). THE TREATING EYE CARE PROFESSIONAL (ECP) REPORTED THE EVENT TO THE (B)(6) ON (B)(6) 2012. THE REPORT STATED THAT ON THE NIGHT OF (B)(6) 2012 THE PT SLEPT IN ACUVUE 2 DEFINE LENSES AND DID NOT REMOVE THE LENSES (ACUVUE 2 DEFINE CONTACT LENSES ARE NOT MARKETED IN THE US). ON (B)(6) 2012, THE PT DEVELOPED PAIN, DISCHARGE AND SEVERE EYELID SWELLING IN THE LEFT EYE (OS). THE PT PRESENTED TO THE TREATING ECP THE SAME DAY AND WAS DIAGNOSED WITH A BACTERIAL ULCER IN THE OS THAT WAS "SLIGHTLY TEMPORAL FROM THE CENTER, ROUND, 1.5-2MM, GROUND-GLASS APPEARANCE." PSEUDOMONAS AERUGINOSA WAS DETECTED FROM A CULTURE OF THE EYE DISCHARGE AND THE CONTACT LENS CASE. VA OS: "UNCORRECTED HAD MOTION AND 20 CM CORRECTED." THE PT WAS INSTRUCTED TO D/C CONTACT LENS WEAR, TREATED WITH VIGAMOX AND BESTRON DROPS Q1HR, NITTEN ATROPINE DROPS BID, TARIVID EYE OINTMENT QID AND TIENAM INFUSION QD. F/U'S: ON (B)(6) 2012 THE SAME TREATMENT WAS CONTINUED. F/U: ON (B)(6) 2012, THE TIENAM INFUSION WAS D/C'D. PRIOR TREATMENT CONTINUED. ON (B)(6) 2012 VA OS: 1.0 (20/20). TREATMENT THE SAME AS F/U (B)(6) 2012. F/U ON (B)(6) 2012: "SOME DEGREE OF RECOVERY OF THE CORNEAL ULCER WAS CONFIRMED. VIGAMOX AND BESTRON DROPS 6X/DAY, TARIVID EYE OINTMENT BID, NITTEN ATROPINE DROPS D/C'D. F/U ON (B)(6) 2012: OS RECOVERED, SLIGHT OPACITY REMAINED. VA OS: 1.0 (20/20). ALL MEDICATIONS WERE D/C'D. F/U ON (B)(6) 2012: NO CHANGE IN DIAGNOSIS OR VA FROM (B)(6) 2012 VISIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other| R