BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 14010969 · Received April 5, 2022

    Report

    Report Number
    2028159-2022-00487
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    February 18, 2022
    Report Date
    July 28, 2022
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    UDI-DI
    00380659981623
    PMA / PMN Number
    K163551
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ALCON LENSX (SITE #(B)(4) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER SITE #(B)(4). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE COMPANY REPRESENTATIVE DID NOT CONFIRM NOR REPLICATE ANYTHING THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. A NON-CONFORMANCE-BASED REVIEW OF THE BATCH/LOT/SERIAL NUMBER WAS PERFORMED. POTENTIAL CONTRIBUTING FACTORS WERE THEN IDENTIFIED. THE FACTORS WERE LATER DEEMED TO HAVE BEEN IRRELEVANT TO THIS REPORTED EVENT. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT/BATCH/SERIAL NUMBER WAS PERFORMED. POTENTIALLY RELEVANT COMPLAINTS (FOR BUTTONHOLES) WERE FOUND RELEVANT TO TWO OTHER COMPLAINTS. THESE TWO COMPLAINTS WERE ALSO ADDRESSED UNDER THE SAME INVESTIGATION (SIMULTANEOUSLY), WITH THE CORRESPONDING SERVICING RECORD (SR). BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE LASER WAS FOUND TO MEET SPECIFICATIONS AND FUNCTION AS INTENDED. THE ROOT CAUSE OF THE REPORTED EVENT IS POTENTIALLY RELATED TO SURGICAL/CLINICAL FACTORS UNRELATED TO THE FUNCTIONALITY OF THE DEVICE. HOWEVER, BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED A BUTTON HOLE DEFECT NOTICED IN THE RIGHT EYE DURING FLAP CREATION. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES PATIENT NUMBER (B)(6) RIGHT EYE AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED. THIS CASE REFERS TO BUTTON HOLE OCCURRED ON (B)(6) 2022. THE REFERENCED CASE PR#(B)(4) REFERS TO THE SAME PATIENT, EVENT OF BUTTON HOLE ON (B)(6) 2022 (REPORT SUBMITTED PREVIOUSLY).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATED, THE PHYSICIAN GOAL IS TO LASER THE FLAP COMPLETELY WITH THE STREAM LIGHT AND THEN THE CORRECTION OF VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62989 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA 00380659981623

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male