BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2653446 · Received January 6, 2009

    Report

    Report Number
    3005087645-2008-00006
    Event Type
    Other
    Date Received
    January 6, 2009
    Report Date
    June 5, 2009
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COULD NOT VERIFY IF LENS IS SYNERGEYES, INC LENS. PT IS (B)(6) AND IS HANDICAPPED. COMPLICATION RARE BUT NOT UNK, NO EVIDENCE OF MALFUNCTION OF THE DEVICE BUT RATHER AN INHERENT RISK OF CONTACT LENS WEAR.

    Description of Event or Problem · 1

    THE PT E-MAILED THE WEBSITE, WWW.SYNERGEYES.COM. THE PT STATED, "I HAVE KERATOKONUS AND AFTER SEVERAL YEARS OF USING SOPER CONTACT LENS, MY OPHTHALMOLOGIST HAD THE OPTOMOLOGIST IN HER OFFICE REFIT ME FOR LENS AND THEY SELECTED SYNERGEYES. I AM (B)(6), HANDICAPPED, AND ON A FIXED INCOME. THE COST OF THE LENS WERE (B)(6) FOR TWO SETS TO LAST FOR 2 YRS. IT TOOK ME ALMOST TWO MONTHS TO BE ABLE TO GET THE MONEY FOR MY CONTACTS. ONCE I RECEIVED THEM, I WAS TOTALLY DELIGHTED. I ENDED UP WITH A TERRIBLE CORNEAL INFECTION THAT WAS TREATED FOR 2 WEEKS. A CORRECTION ON SIZE HAD TO BE MADE ON THE RIGHT EYE, AND IT HAVING BEEN OBTAINED, IS MUCH MORE COMFORTABLE. IN LESS THAN TWO MONTHS WEAR, ONE DAY MY RIGHT EYE BEGAN TO HURT TERRIBLY. I KEPT ADDING MORE LUBRICANT AND FINALLY TOOK THE LENS OUT AND LOOKED AT IT. IT LOOKED TO BE LIKE A SCRATCH ON THE SOFT PORTION OF THE LENS. I LEFT THE LENS OUT FOR THE REST OF THE DAY. THE NEXT DAY I WENT TO PUT THEM IN, AND AGAIN, THE EYE BEGAN TO HURT CONSIDERABLY, SO I TOOK IT OUT AND LOOKED AT IT. THERE IS A TEAR IN THE SOFT PORTION OF THE LENS. CONTACTING MY DR OFFICE, I AM ADVISED THAT THERE IS NO WARRANTY AVAILABLE AND IT IS DOUBTFUL THAT THE COMPANY WILL DO ANYTHING ABOUT THE LENS. UNDER THE CIRCUMSTANCES I RESPECTFULLY REQUEST THAT YOU REPLACE OR REPAIR THE LENS AT A COST THAT IS MORE WITHIN MY BUDGET, AND THAT ADVISE IF THERE IS SOMEPLACE WHERE A YEARS SUPPLY OF LENS ARE NOT (B)(6). IS THERE NO WAY TO REPAIR THE LENS BY REPLACING". THE COMPLAINT FOLLOW-UP FORM WAS COMPLETED BY THE PRACTIONER AND STATED THAT THE "PT HAD A CORNEAL ULCER, THAT WAS HEALED SUCCESSFULLY." "THE PT WAS TREATED SUCCESSFULLY WITH 100% RESOLUTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CONTACT LENS HQD SYNERGEYES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention