BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES ID SINGLE VISION

    MDR report key: 10969315 · Received December 8, 2020

    Report

    Report Number
    3005087645-2020-00003
    Event Type
    Injury
    Date Received
    December 8, 2020
    Date of Event
    November 6, 2020
    Report Date
    December 7, 2020
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    MRC
    UDI-DI
    M738A500090
    PMA / PMN Number
    K083921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2020: (B)(6), OD AT THE EYE CLINIC, INC. EMAILED CONSULTATION DEPARTMENT AT SYNERGEYES TO INFORM THEM THAT HIS PATIENT HAD SUSTAINED AN INJURY. (B)(6)'S EMAIL WAS AS FOLLOWS: "(B)(6), ONE OF MY ID ONE OF MY ID PATIENTS CAME IN YESTERDAY WITH C/O PAIN, REDNESS AND PHOTOPHOBIA. SHE HAS DEVELOPED A PARACENTRAL CORNEAL ULCER. HISTORY REVEALED SHE HAD ACCIDENTLY NAPPED FOR A BRIEF PERIOD OF TIME WHILE WEARING HER LENSES. OF NOTE, THIS PATIENT IS A LONG-TERM DUETTE WEARER WITHOUT ANY PRIOR HISTORY OF COMPLICATIONS. SHE REPORTED AT DISPENSE GOOD COMFORT (BETTER THAN DUETTE) AND GOOD VISION. THE FIT APPEARED IMPROVED RELATIVE TO DUETTE AS WELL (BETTER LENS MOVEMENT). SHE WAS DUE TO SEE ME TODAY FOR HER FINAL FOLLOW UP VISIT, BUT WE HAVE OBVIOUSLY DEFERRED THAT UNTIL WE CAN GET THE ULCER HEALED. THE ULCER IS SMALL, < 0.5 MM. I HAVE HER ON AGGRESSIVE ANTIMICROBIAL THERAPY, AND EXPECT SHE WILL HAVE TOTAL RESOLUTION OF SIGNS AND SYMPTOMS. MY GUT IS THAT THIS EVENT IS NOT RELATED TO THE CHANGE IN LENS DESIGN. HOWEVER, GIVEN THAT WE ARE IN AN EVALUATION PERIOD, I FELT IT WAS IMPORTANT TO REPORT THIS TO YOU. I WILL KEEP YOU APPRISED OF HER PROGRESS. IF YOU NEED ANY FURTHER INFORMATION FROM ME AT THIS TIME, PLEASE FEEL FREE TO CONTACT ME. (B)(6)" CONSULTATION WILL FOLLOW UP WITH ECP TO GET PRODUCT COMPLAINT FORM AND PATIENT INJURY FORM FILLED OUT. (B)(6) 2020: CONSULTATION ((B)(6)) SENT QF8553 PATIENT INJURY FORM TO DR. (B)(6) TO HAVE IT FILLED OUT. (B)(6) 2020: QA EMAILED CONSULTATION TO SEE IF THE ECP HAD RETURNED PRODUCT COMPLAINT FORM OR IF THERE WAS ANY MORE INFO REGARDING THIS POSSIBLE INJURY. (B)(6) 2020: QA HAS NOT RECEIVED ANY PAPERWORK OR LENSES REGARDING THIS POTENTIAL INJURY AS OF YET. (B)(6) 2020: CONSULTATION REPLIED STATING THEY HAD NOT HEARD BACK FROM THE ECP YET. CONSULTATION WOULD REACH OUT TO THE DOCTOR AGAIN. (B)(6) 2020: QA EMAILED CONSULTATION FOR FOLLOW-UP TO THE EMAIL FROM 2020-11-23. (B)(6) 2020: CONSULTATION REPLIED THE FOLLOWING- "YES. HE IS STILL TREATING HER AND ONCE THE ULCER ISSUE HAS RESOLVED, HE WILL RESUME HER CONTACT LENS WEAR. IT IS NOT A CONTACT LENS RELATED ISSUE. I AGAIN ASKED HIM TO FILL OUT THE FORM, BUT STILL HAVEN'T RECEIVED IT". (B)(6) 2020: SYNERGEYES DECIDED TO FILE MEDWATCH FORM 3500A BASED ON DECISION POINT 4E OF MDR DETERMINATION FORM. PATIENT USING "AGGRESSIVE ANTIMICROBIAL THERAPY" AND DR. EXPECTS "TOTAL RESOLUTION OF SIGNS AND SYMPTOMS." DECISION POINT 4F: PATIENT WORE THE LENS WHILE SLEEPING, INSTRUCTIONS STATE NOT TO DO THIS. REPORT MDR B/C SYMPTOMS NOT RESOLVES AS OF YET. DR. (B)(6) STATES IN HIS EMAIL HE DOES NOT BELIEVE THE INJURY IS CONTACT LENS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429415 SYNERGEYES ID SINGLE VISION DAILY WEAR HYBRID CONTACT LENS, PRODUCT CODE: HQD, PRODUCT CODE: HQD MRC SYNERGEYES, INC. ZS806460-0375CT 093037 M738A500090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention