BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES HYBRID CONTACT LENS

    MDR report key: 4223261 · Received October 27, 2014

    Report

    Report Number
    3005087645-2014-00025
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    August 19, 2014
    Report Date
    October 27, 2014
    Manufacturer
    SYNERGEYES
    Product Code
    HQD
    PMA / PMN Number
    K052675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: 058465, PART NUMBER: KS6179-1550, EXPIRATION DATE: 05/01/2019. 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 THE SKIRTS OF BOTH LENSES WERE TORN, SUCH AN OCCURRENCE IS CONSISTENT WITH REGULAR PATIENT 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 ABRASION. REPORT STATED THAT THE PATIENT (PT) WAS ALLEGEDLY INJURED WHILE WEARING THE LENS, THAT THE ALLEGED INJURY DID NOT HEAL ON ITS OWN HAVING REQUIRED A PRESCRIPTION OF, "ZYLET BID." PT HAD PRE-EXISTING CONDITION OF KERATOCONUS, THE REPORT ALSO STATED THAT THE PT HAD CONTRIBUTED TO THE ALLEGED INJURY BY NOT OBSERVING THAT THE CONTACT LENSES HAD TORN OR CHIPPED SKIRTS AND STILL USING THEM. FROM (B)(6) 2014, FIVE ATTEMPTS TO CONTACT THE ECP WERE MADE. ON (B)(6) 2014 SYNERGEYES RECEIVED THE FOLLOWING INFORMATION FROM (B)(6): ABRASION WAS IN BOTH EYES (OU). CONFIRMED THAT PT HAS KERATOCONUS. (B)(6) STATED THAT THE ECP BELIEVES THAT THE ABRASION PENETRATED THE CORNEAL EPITHELIUM. USE OF PRESCRIPTION MEDICATION ZYLET WAS CONSIDERED BY THE DOCTOR TO BE THERAPEUTIC. PT STILL HAS "SLIGHT CORNEAL SCARRING, THOUGH IT IS HEALING." PT HAD BEEN IN THAT MORNING AND (B)(6) STATED THAT THE ECP'S DIAGNOSIS WAS THAT THE PATIENT HAD "KERATOCONUS AND EPIPHORA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681076 SYNERGEYES HYBRID CONTACT LENS CONTACT LENS HQD SYNERGEYES KC6179-1550 058751

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention