BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASYS BRAND CONTACT LENSES

    MDR report key: 1707445 · Received June 1, 2010

    Report

    Report Number
    1033553-2010-00032
    Event Type
    Injury
    Date Received
    June 1, 2010
    Date of Event
    April 19, 2010
    Report Date
    June 1, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6)2010, A PATIENT CONTACTED JOHNSON & JOHNSON VISIONCARE, VISTAKON, TO REPORT BEING DIAGNOSED WITH AN INFECTIOUS CORNEAL ULCER OD WHILE WEARING OAYSIS LENSES. THE PT REPORTED BEING NEW TO THE PRODUCT, ORDERED THE LENSES FROM AN ONLINE COMPANY IN 3/2010 AND STARTED WEARING THE LENSES ON (B)(6)2010. THE PT'S PRIMARY EYE CARE PROFESSIONAL CONFIRMED THAT THE PT'S LAST EYE EXAM WAS IN (B)(6)2009 AND THAT THE PT DID NOT HAVE A VALID PRESCRIPTION FOR OASYS PRODUCT. THE PT PRESENTED TO AN OPHTHALMOLOGIST (B)(6)2010. CHART INDICATES: "PT WAS WEARING CTL OVERNIGHT X1 WEEK BEGAN HAVING PAIN, REDNESS, TEARING, LIGHT SENSITIVITY OD, SATURDAY TOOK OUT CTL, SUNDAY OU NO IMPROVEMENT." CHART NOTES 2-3 +INJECTION OD AND TRACE INJECTION OS. VA: 20/25+2 OD 20/20+1 OS WITH GLASSES. DRAWING DEPICTS 0.5MM CORNEAL INFILTRATE WITH STAIN AT 7 O'CLOCK, CORNEAL EDEMA OD. DRAWING ALSO DEPICTS SPK OS. CHART NOTES: TOPICAL ANESTHESIA RELIEVES PAIN. LIKELY SMALL CORNEAL ULCER OD. VIGAMOX EVERY 1 HR OD WHILE AWAKE. NO CL NEAR OU. FEW SPK OS. VIGAMOX ON PRESCRIPTION OS. ON (B)(6)2010 F/U: "PAIN, RED, LIGHT SENSITIVE OD. VA 20/20-1 OU WITH GLASSES. HEALING K ULCER OD. VIGAMOX EVERY 2 HRS OD. NEG SPK OS VIGAMOX ON PRESCRIPTION OS X3 DAY." ON (B)(6)2010 F/U: "PT HASN'T NOTICED MUCH CHANGE OD + LIGHT SENSITIVE AND DISCOMFORT." VA: 20/30 OU W/GLASSES. PINPOINT INFILTRATE, DECREASED K- EDEMA -STAIN OD PER DRAWING. MUCH IMPROVED K ULCER OD. RESOLVED SPK OS. STOP VIGAMOX OS. VIGAMOX OD ON PRESCRIPTION UNTIL NEXT APPOINTMENT. NO CL WEAR. ON (B)(6)2010 F/U: "RIGHT EYE PAIN RETURNED FRIDAY (B)(6)2010. INCREASED REDNESS OD. NEG PROBLEMS OS. PT RAN OUT OF VIGAMOX (B)(6)2010. PT RESTARTED VIGAMOX (B)(6)2010 EVERY 1-2 HRS OD." VA; 20/25-1 OD AND 20/20-1 OS. DRAWING DEPICTS 0.25 INFILTRATE WITH STAIN IN PRIOR LOCATION AND QUESTIONABLE INFILTRATE VS K EDEMA 0.5 X 1.5MM AT 7 O'CLOCK SAME LOCATION. "K ULCER OD WORSENING OD LIKELY 2/2 (SECONDARY TO) PT STOPPING ABX TOO SOON. PT NOTES DECREASED SYMPTOMS OD WHEN SHE RESTARTED ABX (B)(6)2010. VIGAMOX EVERY 1 HR OD. NO CL WEAR. IF NO IMPROVEMENT, CONSIDER REFERRAL TO A CORNEAL SPECIALIST FOR CULTURING AND FURTHER TREATMENT." F/U ON (B)(6)2010: "INCREASED LIGHT SENSITIVITY OD X1HR. NEG CHANGE REDNESS, PAIN OD." VA: "20/400 OU. DR. FORGOT GLASSES." DRAWING DEPICTS "0.25 INFILTRATE AND 0.5 X 1.75 INFILTRATE VS K EDEMA OD. K ULCER OD: K ULCER NOT RESPONDING TO VIGAMOX EVERY 1 HR OD AND POSSIBLY SLIGHTLY WORSE. CONT VIGAMOX EVERY 1 HR UNTIL SEEN BY THE CORNEAL SPECIALIST." CHART FROM THE CORNEAL SPECIALIST INDICATES THAT THE PT WAS REFERRED ON (B)(6)2010 FOR EVALUATION FOR AN "INFECTION OD." CHART INDICATES "PT WAS WEARING EWSCL (EXTENDED WEAR SOFT CONTACT LENSES) NEW CL FOR HER. SHE STATES PAIN, WATERING, REDNESS, PHOTOPHOBIA. PT STATES PROBLEMS WITH RIGHT EYE SINCE (B)(6)2010." DR. NOTED "VA: OU 20/20 WITH GLASSES. OS CLEAR. 2+ INJECTION OD. INFERIOR PARACENTRAL INFILTRATE 2MM WITH INTACT EPITHELIUM. AC DEEP WITH MILD FLARE AND CELL, NO HYPOPYON. RESOLVING CORNEAL ULCERATION OD SECONDARY TO EWSCL. REC. CONTINUE VIGAMOX EVERY 2 HRS OD WHILE AWAKE, ADD TOBRADEX ON PRESCRIPTION AND GIVEN MYDRIACYL. CHECK IN 2 DAYS. STAY OUT OF CL FOR NOW. REC NO LONGER EWSCL IN FUTURE. SHOULD DO WELL." F/U ON (B)(6)2010 CHART INDICATES: "VA SEEMS GOOD, FEELING BETTER, STATES THAT SHE MAY NEED TO USE ANTIBIOTICS A LITTLE LONGER BASED ON CONTINUED IRRITATION IN THE MORNING. VA: OC FC@2 PH 20/80. OS 20/25 W/CL'S. OS CLEAR OD INF PARACENTRAL INFILTRATE 1MM WITH INTACT EPI. AC: DEEP WITH MILD FLARE AND CELL, NO HYPOPYON. IMPROVING. CONTINUE WITH VIGAMOX AND TOBRADEX TID OU AND RECHECK IN 1 WEEK OR PRN IF ANY INCREASE REDNESS, DISCOMFORT OR CHANGES IN VISION." F/U ON (B)(6)2010 CHART INDICATES: "PATIENT REPORTS OD SEEMS TO BE MUCH BETTER. USING GTTS AS DIRECTED. VA 20/20 OU WITH GLASSES. SCLERA OU QUIET. AC OD DEEP WITH MILD FLARE AND CELL. OD INF PARACENTRAL INFILTRATE 0.5MM WITH INTACT EPI. OS CLEAR. CORNEAL ULCERATION OD RESOLVING. ANTIBIOTICS TID UNTIL END OF WEEK, THEN FLAREX QD X2 WEEKS. CHECK IN 1 MONTH PRN." THE PRODUCT IN QUESTION HAS BEEN REQUESTED FOR EVALUATION AND PER THE PATIENT IS ENROUTE VIA MAIL BUT HAS NOT YET BEEN RECEIVED. WILL REPORT ANY ADDITIONAL INFORMATION WITHIN 30 DAYS UPON RECEIPT. ALL MDR REPORTS ARE REVIEWED AT QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention