BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUETTE PROGRESSIVE CN

    MDR report key: 9733982 · Received February 20, 2020

    Report

    Report Number
    3005087645-2020-00001
    Event Type
    Injury
    Date Received
    February 20, 2020
    Date of Event
    January 9, 2020
    Report Date
    February 17, 2020
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    UDI-DI
    M738A500090
    PMA / PMN Number
    K153174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON 2020-01-29: LENS IN FLAT PACK AND PRODUCT COMPLAINT FORM RECEIVED AT CUSTOMER CARE/RETURNS DEPARTMENT. ECP HAD CHECKED OFF YES STAINING PRESENT AND IT INDICATES A CORNEAL INJURY. THE COMPLAINT CODE WAS (B)(4) DEFECTIVE OTHER- SMALL TEAR/RIP BETWEEN THE SKIRT AND RGP CENTER. ON 2020-01-31: CUSTOMER CARE EMAILED CONSULTATION AND QA TO INFORM ABOUT THIS POSSIBLE INJURY AND TO HAVE CONSULTATION CONTACT THE EYE CARE PROFESSIONAL ((B)(6)) AND REQUEST THEM TO SEND THE PATIENT INJURY FORM AND MORE DETAILS. ON 2020-02-11: CONSULTATION SPOKE WITH (B)(6) THE CONTACT PERSON FOR THE ATTENDING PHYSICIAN. POSSIBLE INJURY REPORTED WAS 105 OTHER INJURY- CENTRAL MODERATELY DENSE SPK (SUPERFICIAL PUNCTATE KERATITIS) WITH MILD PEK (PUNCTATE EPITHELIAL KERATOCONJUNCTIVITIS). THE EVENT WAS NOT TRANSIENT NOR DID IT RESOLVE ON ITS OWN. THE DOCTOR IS UNCERTAIN IF THE EVENT WAS CAUSED BY PATIENT USE AND OR HANDLING. PATIENT REQUIRED THERAPEUTIC TREATMENT TO RESOLVE THE INJURY. TREATMENT ADMINISTERED WAS NEOPOLYDEX OPHTHALMIC DROPS ON (B)(6) 2020 4 TIMES A DAY. BEGAN TO TAPER DOSE AND D/C AFTER 5 DAYS ON (B)(6) 2020. THE CONDITION HAS BEEN RESOLVED AS OF (B)(6) 2020 WITH NO COMPLICATIONS. PRODUCT COMPLAINT FORM PART 7 - PRACTITIONER COMMENTS: PATIENT REMOVED LENS FRIDAY (B)(6) 2020, AWOKE SAT (B)(6) 2020, WITH RED CRUSTY SENSATION, FOREIGN BODY SENSATION. PATIENT BEGAN USING ARTIFICIAL TEARS AT HOME. SHE PHONED THE OFFICE (B)(6) 2020 WAS DIAGNOSED WITH AN INFECTION (MILD DENSE SPK AND MILD PEK) NEOPOLYDEX DROPS WERE GIVEN. PATIENT SEEN AGAIN (B)(6) 2020 BEGAN TAPER OFF DROPS FROM 4/D TO 1/D AND DISCONTINUED IN 5 DAYS. MINOR SPK ON (B)(6) 2020. PATIENT HAD A TEAR IN SKIRT OF LENS ON (B)(6) 2020. DUE TO THE FACT PATIENT DID NOT CALL NOR COME IN FOR 7 DAYS. IT IS UNCERTAIN IF THE INFECTION (SPK) WAS CONTACT LENS RELATED OR NOT. PATIENT HAD DIFFICULTY REMOVING THE LENS IN OFFICE. THE DR. IS CONSIDERING A SKIRT OR BASE CURVE CHANGE, PENDING PATIENT REPORT IF SHE CALLS BACK WITH COMPLAINT. ON 2020-02-13: QA EVALUATED THE RETURNED LENS. LENS WAS RECEIVED COMPLETELY DRY AND HARD IN FLAT PACK. SOAKED LENS IN SALINE FOR 1 HOUR, LENS WETTED AFTER SOAKING AND DEBRIS CAME OFF WITH SALINE AND SWAB. MEASURED LENS BASE CURVE (7.6) IS AN EXACT MATCH TO SPECIFICATION. MEASURED LENS POWER (+0.75) IS WITHIN SPECIFICATION. FOUND THREE TEARS (JUNCTION AREA) AND CLOUDY SKIRT AT SURFACE INSPECTION. TEARS ARE CONSISTENT WITH PATIENT CARE AND HANDLING. CLOUDY SKIRT IS CONSISTENT WITH CLEANING SOLUTION. DOCTOR STATES THAT DUE TO THE FACT PATIENT DID NOT CALL NOR COME IN FOR 7 DAYS IT IS UNCERTAIN IF THE INFECTION (SPK) WAS CONTACT LENS RELATED OR NOT. THE CONDITION HAS BEEN RESOLVED AS OF (B)(6) 2020 WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195833 DUETTE PROGRESSIVE CN DAILY WEAR HYBRID CONTACT LENS, PRODUCT CODE: HQD HQD SYNERGEYES, INC. SP76S+0100+025030 099318 M738A500090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention