BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILIGHT

    MDR report key: 18268948 · Received December 5, 2023

    Report

    Report Number
    3021349626-2023-00019
    Event Type
    Injury
    Date Received
    December 5, 2023
    Report Date
    December 5, 2023
    Manufacturer
    LUMENIS BE LTD
    Product Code
    QIU
    PMA / PMN Number
    K193500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 11/12/23 LUMENIS RECEIVED AN ATTORNEY LETTER FROM TEXAS EYE SURGEONS, PA CLAIMING THERE WAS AN INJURY CAUSED BY THE OPTILIGHT UNIT SOLD TO THIS CUSTOMER. NO SYSTEM TYPE WAS REPORTED AND NO TREATMENT INFORMATION OR PATIENT INJURY INFORMATION WAS INCLUDED - ONLY A NEBULOUS ALLEGATION OF INJURY. A SEARCH OF THE LUMENIS COMPLAINT DATABASE FOUND NO COMPLAINTS REGARDING INJURY FROM THIS FACILITY. THE OPTILIGHT SYSTEM THEY OWN HAD FOUR PREVIOUS COMPLAINTS FROM LAST YEAR AND EARLIER THIS YEAR (TWO MINOR INSTALLATION ISSUES AND TWO MORE MINOR CORRECTIVE ISSUES (DONGLE CONNECTION AND FILTER ISSUE)) BUT NOTHING TO SUGGEST ANY POTENTIAL FOR INJURY. SEVERAL ATTEMPTS TO OBTAIN INFORMATION WERE MADE TO TEXAS EYE SURGEONS WITHOUT SUCCESS. THE CHU AND CRU TEAMS INDEPENDENTLY CALLED AND EMAILED INCIDENT FORMS TO THE FACILITY MULTIPLE TIMES AND EVENTUALLY WERE TOLD THAT THEY WOULD NOT SPEAK WITH US BUT INSTEAD, WERE TO COMMUNICATE VIA THE LEGAL TEAMS. WITH NO FURTHER COMMUNICATION ALLOWED A CONVERSATION REGARDING HAVING A SERVICE VISIT TO EVALUATE THE SYSTEM WAS NOT POSSIBLE. THE LUMENIS LEGAL REPRESENTATIVE SENT AN INCIDENT FORM TO THE PHYSICIAN LAWYER VIA EMAIL ON 11/21/23 BUT RECEIVED NO RESPONSE FROM THE TEXAS EYE LAWYER. ALL HE HAS RECEIVED WAS THE ORIGINAL STATEMENT; "THE EQUIPMENT AS DELIVERED WAS DAMAGED, NEEDED REPAIRS, COULD ONLY BE USED FOR PATIENTS OF A CERTAIN SKIN COLOR, AND OPERATES DEFECTIVELY SUCH THAT IT HAS CAUSED BURNS TO AT LEAST ONE PATIENT AND THEREFORE ITS USE CANNOT BE RISKED ON OTHER PATIENTS." AS SUCH, WITH NO EVENT INFORMATION SHARED AND NO COMMUNICATION WITH THE FACILITY REGARDING THE SYSTEM THE INVESTIGATION HAS PROVEN FRUITLESS. A REVIEW OF THE OPTILIGHT (MODEL GA-0005500 SERIAL NUMBER (B)(6) DHR RECORDS SHOWED THAT THE SYSTEM WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE AND SHIPPED ACCORDING TO SPECIFICATIONS. THE SYSTEM PASSED ALL TESTING AND MET ALL LUMENIS SPECIFICATIONS PRIOR TO THE RELEASE FOR SALE. THE INSTALLATION DATE WAS 7/5/22. AS A RESULT OF HAVING LITTLE OR NO EVENT INFORMATION REGARDING A SERIOUS INJURY THE FDA REPORTING DECISION TREE CONCLUDES THAT THIS EVENT IS NOT REPORTABLE. HOWEVER, LUMENIS WILL, IN AN ABUNDANCE OF CAUTION, REPORT THIS EVENT TO THE FDA AS MDR #3021349626-2023-00019. LUMENIS WILL CONTINUE TO MONITOR THE EVENT AND AS ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. LUMENIS WILL CLOSE THIS COMPLAINT AT THIS TIME. COMPLAINT TRENDING WILL CONTINUE TO MONITOR PER GLOBAL COMPLAINT HANDLING SOP DOC NO. (B)(4) AND PER POST MARKETING SURVEILLANCE PROCEDURE DOC NO. (B)(4).

    Description of Event or Problem · 0

    REPORT OF POSSIBLE OPTILIGHT ADVERSE EVENT - REPORTED TO LEGAL BUT NO DETAILS ON EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065531 OPTILIGHT STELLAR M22 FOR INTENSE PULSED LIGHT (IPL) AND LASER SYSTEM, PRODUCT CODE: GEX QIU LUMENIS BE LTD OPTILIGHT STELLAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other