BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES HYBRID CONTACT LENS

    MDR report key: 4223260 · Received October 27, 2014

    Report

    Report Number
    3005087645-2014-00026
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 27, 2014
    Manufacturer
    SYNERGEYES
    Product Code
    HQD
    PMA / PMN Number
    K083921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION THE FOLLOWING INFORMATION WAS OBTAINED: A SECOND LENS WAS RETURNED AS PART OF THE SAME COMPLAINT. ITS SPECIFICATIONS WERE DETERMINED TO BE AS FOLLOWS: LOT NUMBER: 058175, PART NUMBER: SA81Y+0350, EXPIRATION DATE: 04/01/2019. THE BASE CURVE (BC) WAS MEASURED BY RADIUS SCOPE AND POWER WAS MEASURED BY LENSOMETER FOR BOTH LENSES. FOR BOTH LENSES, THE BC AND POWER WERE FOUND TO BE WITHIN SPECIFICATIONS. ALTHOUGH IRREMOVABLE DEPOSITS WERE FOUND ON THE SURFACE OF BOTH LENSES, THIS KIND OF INCIDENT CAN OCCUR DURING REGULAR PT USE. NO CORRELATION WAS FOUND BETWEEN THE ALLEGED INJURY AND THE DEVICE HISTORY REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, SYNERGEYES RECEIVED A COMPLAINT WHEREIN THE REASON FOR RETURN WAS A CORNEAL ULCER. REPORT STATED THAT THE ULCER DID NOT HEAL ON ITS OWN, THE PRESCRIPTION WAS LISTED AS, "ANTIBIOTIC, CILOXAN QID, CONDITION IMPROVED." THE REPORT ALSO STATED THAT THE PATIENT HAS THE PRE-EXISTING OR RECURRING CONDITION OF DRY-EYE SYNDROME. FROM (B)(6) 2014, FIVE ATTEMPTS WERE MADE TO CONTACT THE ECP TO ATTAIN MORE INFORMATION. ON (B)(6) 2014, (B)(6), WAS REACHED AND THE FOLLOWING INFORMATION WAS OBTAINED: ULCER WAS ALLEGEDLY IN THE RIGHT EYE (OD). PT HAS RECURRING CONDITION DRY EYE SYNDROME AND NO OTHERS HAVE BEEN IDENTIFIED IN THIS PATIENT. (B)(6) STATED THAT DR. (B)(6) HAD INFORMED HER THAT THE USE OF CILOXAN WAS THERAPEUTIC. AS OF (B)(6) 2014, THE PT WAS DOING WELL AND USING THE NEW LENS RECEIVED FROM SYNERGEYES WITH MODERATION AND HAD REPORTED THAT THE LENS WAS "CLEAR AND COMFORTABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681374 SYNERGEYES HYBRID CONTACT LENS CONTACT LENS HQD SYNERGEYES SA81Y+0200 054234

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention