BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES HYBRID DAILY CONTACT LENS

    MDR report key: 3827845 · Received May 12, 2014

    Report

    Report Number
    3005087645-2014-00011
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    March 20, 2014
    Report Date
    May 9, 2014
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    PMA / PMN Number
    K061120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION THE FOLLOWING INFORMATION WAS OBTAINED: LENS SURFACE WAS INSPECTED USING AN OPTICAL MICROSCOPE. THERE WAS SIGNIFICANT DEBRIS/FILM OF OPTIC; INDICATIVE OF WEAR FOR SEVERAL DAYS/WEEKS. MINOR CLOUDING OF SKIRT INDICATIVE OF WEAR FOR SEVERAL DAYS/WEEKS. SIGNIFICANT (3-4 MM) TEAR IN THE SKIRT PROXIMAL TO GP JUNCTION - INDICATIVE OF WEAR FOR SEVERAL DAYS/WEEKS AND INDICATIVE OF DAMAGE BY THE PATIENT OR ECP DAMAGE IS CONSISTENT WITH PINCHING THE LENS TOO HARD DURING REMOVAL; DAMAGING THE LENS.

    Description of Event or Problem · 1

    ON 2014 SYNERGEYES RECEIVED A COMPLAINT WHEREIN THE PATIENT EXPERIENCED A "FOREIGN BODY" SENSATION WHILE WEARING THE CONTACT LENS. SYNERGEYES CONTACTED (B)(6) OD, THE ATTENDING (B)(6) AT THE UNIVERSITY EYE ASSOCIATES ON (B)(6) 2014 DETERMINED THE FOLLOWING ADDITIONAL INFORMATION. ON APPROXIMATELY (B)(6) 2014, THE PATIENT CONTACTED THE (B)(6) AND STATED THAT THE CONTACT LENS WAS UNCOMFORTABLE. THE PATIENT WAS INSTRUCTED BY THE ECP TO DISCONTINUE THE USE OF THE LENS. THE PATIENT WAS NOT SEEN BY THE ECP. ON APPROXIMATELY (B)(6) 2014, THE PATIENT AGAIN REPORTED DISCOMFORT WHILE WEARING THE CONTACT LENS. THE ECP AGAIN INSTRUCTED THE PATIENT TO DISCONTINUE THE USE OF THE LENS. THE PATIENT WAS NOT SEEN BY THE ECP. THE PATIENT WAS EXAMINED BY THE ECP ON (B)(6) 2014 WHEREIN THE PATIENT WAS FOUND TO HAVE A SMALL SUPERFICIAL PUNCTATE KERATOPATHY (SPK) AND MINOR STAINING IN TH E LEFT EYE. THERE WAS NO ABRASION OR OTHER CORNEAL DEFECT DETECTED DURING THE EXAMINATION. THE LENS WAS INSPECTED BY THE ECP WHO DETERMINED THAT THERE WAS A "FRACTURE IN THE LENS MATERIAL." THE ECP ADVISED THE PATIENT TO DISCONTINUE THE USE OF THE CONTACT LENS AND UNDERGO TREATMENT. PATIENT TREATMENT CONSISTED OF DISCONTINUING THE USE OF THE LENS AND WEARING AN "AIR-OPTIX DAY AND NIGHT" BANDAGE OVER THE LEFT EYE FOR 24 HOURS. THE PATIENT HAS A PRE-EXISTING CONDITION (KERATOCONUS) WHICH MAY HAVE CONTRIBUTED TO THE EVENT. ALSO THE PATIENT WORE THE FRACTURED CONTACT LENS AFTER BEING ADVISED TO DISCONTINUE THE USE OF THE LENS. ON (B)(6) 2014, THE PATIENT WAS SEEN BY THE ECP. THE PATIENT WAS DOING "FINE" AND THE SPK HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283351 SYNERGEYES HYBRID DAILY CONTACT LENS CONTACT LENS HQD SYNERGEYES, INC. CK25S-0050 055056

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention