BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES HYBRID DAILY CONTACT LENS

    MDR report key: 3848414 · Received April 18, 2014

    Report

    Report Number
    3005087645-2014-00009
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 9, 2014
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    PMA / PMN Number
    K052675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION THE FOLLOWING INFO WAS OBTAINED: LENS SURFACE WAS INSPECTED USING AN OPTICAL MICROSCOPE. NO SURFACE DEFECTS WERE DETECTED. BASE CURVE WAS MEASURED USING A RADIUSCOPE. THE LENS' MEASURED PARAMETER WAS WITHIN THE LENS DESIGN SPECIFICATION. POWER WAS MEASURED USING A LENSOMETER. THE LENS' MEASURED POWER WAS WITHIN THE LENS DESIGN SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(4) 2014 SYNERGEYES RECEIVED A COMPLAINT FROM (B)(6) REGARDING PT WITH KERATOCONUS WHO HAD SUSTAINED A CORNEAL ABRASION/EDEMA WHILE WEARING SYNERGEYES CONTACT LENSES. THE (B)(6) WAS CONTACTED ON (B)(4) 2014 FOR ADDITIONAL EVENT INFO. IN RESPONSE TO OS IRRITATION, THE PT WENT TO OPHTHALMOLOGIST DR (B)(6). DR (B)(6) TREATED THE PT'S SYMPTOMS AS AN INFECTION. MOREOVER, DR (B)(6) STATED THAT THE IRRITATION WAS LENS RELATED AND SENT THE PT BACK TO VISION SOURCE FOR A FOLLOW UP. VISION SOURCE DID NOT HAVE ANY ADDITIONAL INFO REGARDING DATE, TREATMENT, OR MEDICATIONS ADMINISTERED BY DR (B)(6). ON (B)(6) 2014 THE PT WAS SEEN BY (B)(6) FOR A FOLLOW UP WITH DR (B)(6) WHO INSTRUCTED THE PT TO DISCONTINUE USE OF THE LENS. DR (B)(6) THEN ADVISED THE PT TO CHANGE THEIR STORAGE AND CLEANING SOLUTION TO CLEARCARE TO ELIMINATE IT AS THE SOURCE OF THE OS IRRITATION. DR (B)(6) STATED IN THE PT'S RECORD THAT THE IRRITATION AND SUBSEQUENT CORNEAL ABRASION/ EDEMA WERE DUE TO APICAL TOUCHING OF THE OS LENS ON THE CORNEA. ON (B)(6) 2014 ON FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238755 SYNERGEYES HYBRID DAILY CONTACT LENS CONTACT LENS HQD SYNERGEYES, INC. KS6585-0750 052266

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention