BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE

    MDR report key: 21619875 · Received March 17, 2025

    Report

    Report Number
    3012236936-2025-000073
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    February 17, 2025
    Report Date
    February 17, 2026
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    UDI-DI
    05050474534476
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, A5 AND A6: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6A - IMPLANT DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. SECTION E1 - FIRST/GIVEN NAME: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - LAST NAME: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - EMAIL ADDRESS: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6 -HEALTH EFFECT - CLINICAL CODE: 4581: SHALLOWING OR COLLAPSING OF THE ANTERIOR CHAMBER. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: THE FOLLOWING INFORMATION WAS INADVERTENTLY LEFT OUT THE INITIAL REPORT 3012236936-2025-0000730 WHICH WAS SUBMITTED ON THE 17TH MARCH 2025. ADDITIONAL INFORMATION WAS PROVIDED AND IT WAS LEARNT THAT THE PATIENT DIDN'T PRESENT ANY ISSUES AFTER SURGERY AND THE VISUAL ACUITY WAS GOOD. NO FURTHER INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: THE SYSTEM WAS EVALUATED BY THE ENGINEER AND NO MALFUNCTIONS WERE FOUND DURING THE EVALUATION. THE SYSTEM IS PERFORMING IN ACCORDANCE WITH COMPANY SPECIFICATIONS. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIRTY MINUTES AFTER STARTING THE SYSTEM, AN ALARM SOUNDED, INDICATING "360 IH FLUIDICS - READ ERROR. THE PATIENT'S ANTERIOR CHAMBER COLLAPSED AND THE ANTERIOR CAPSULE ROSE AND BROKE. THERE WAS AN ERROR DURING STARTUP. THE ACCOUNT ALSO INDICATED THAT HE HAD RAISED THE BOTTLE BECAUSE THE CAPSULE ROSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186662 WHITESTAR SIGNATURE UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC NGP680300 05050474534476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other