BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PC-60R

    MDR report key: 17566043 · Received August 17, 2023

    Report

    Report Number
    3006723646-2023-00413
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    June 10, 2023
    Report Date
    November 21, 2023
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP #1 EMDR IS BEING SUBMITTED TO FDA FOR AN EVENT THAT OCCURRED OUTSIDE OF THE USA. THE REPORT INCLUDES ADDITIONAL INFORMATION NOT AVAILABLE/INCLUDED IN THE INITIAL REPORT. ADDITIONAL INFORMATION: G6 - TYPE OF REPORT - NOTED AS FOLLOW-UP #1. H2 - TYPE OF FOLLOW-UP - NOTED FOR ADDITIONAL INFORMATION. H6 - ADDED CODES FOR MANUFACTURER'S INVESTIGATION: TYPE; FINDINGS; AND CONCLUSION. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIALNO.: (B)(6); MODEL: PC-60R). FROM OUR INVESTIGATION, WE COULDN'T CONFIRM THE REPORTED EVENT. NO ROOT CAUSE WAS DETERMINED BASE ON FINDINGS OF INVESTIGATION RESULT. HOWEVER, BASED ON AVAILABLE INFORMATION, WE BELIEVE THIS EVENT WAS NOT CAUSED BY OUR PRODUCT QUALITY.

    Additional Manufacturer Narrative · 0

    THIS INITIAL EMDR IS BEING SUBMITTED TO FDA FOR OUTSIDE US LIKE PRODUCTS REPORTING. REGARDING SECTION H6 - MANUFACTURER'S CODES FOR: TYPE OF INVESTIGATION, FINDINGS, AND CONCLUSION ARE PENDING COMPLETION OF PRODUCT INVESTIGATION. ONCE THE PRODUCT INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA WHICH WILL INCLUDE THE MANUFACTURER'S CODES FOR TYPE OF INVESTIGATION, FINDINGS, AND CONCLUSION.

    Description of Event or Problem · 0

    EVENT OCCURRED IN BRAZIL. TECHNICAL COMPLAINT REPORTED BY HOSPITAL DIRECTLY TO ANVISA. TUCKING FAILURE; PROBLEM CODE: A040603 FAILURE TO FOLD. PATIENT IMPACT: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

    Description of Event or Problem · 0

    EVENT OCCURRED IN BRAZIL. TECHNICAL COMPLAINT REPORTED BY HOSPITAL DIRECTLY TO ANVISA TUCKING FAILURE. PROBLEM CODE: A040603 FAILURE TO FOLD. PATIENT IMPACT: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994161 PC-60R INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. PC-60R (+ 19.50 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other