BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLARIS VISION ENHANCEMENT SYSTEM

    MDR report key: 5591620 · Received April 20, 2016

    Report

    Report Number
    0001920664-2016-00153
    Event Type
    Injury
    Date Received
    April 20, 2016
    Date of Event
    November 6, 2015
    Report Date
    March 22, 2016
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT NUMBER WAS NOT PROVIDED; THEREFORE THE STERILIZATION AND LOT HISTORY RECORDS COULD NOT BE REVIEWED. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN. SEE RELATED REPORTS: PATIENT 1 1920664-2016-00153, 1920664-2016-00154, 1920064-2016-00155, 1313525-2016-00159. PATIENT 2 1920664-2016-00156, 1920664-2016-00157, 1920664-2016-00158, 1313525-2016-00160. PATIENT 3 1920064-2016-00159, 1920064-2016-00160, 1920064-2016-00161, 1313525-2016-00161.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 PATIENTS DEVELOPED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) OF UNKNOWN ETIOLOGY POST CATARACT SURGERY (THE DATE OF SURGERY WAS (B)(6) 2015). REPORTEDLY THE PATIENTS WERE REFERRED TO A RETINAL SURGEON. PER THE INFORMATION RECEIVED ONE PATIENT WAS IMPROVING, ANOTHER PATIENT REQUIRED A CORNEA TRANSPLANT, AND THE THIRD PATIENT WAS NOT IMPROVING AND REMAINED UNABLE TO SEE OUT OF THE AFFECTED EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. THIS REPORT REFERENCES PATIENT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242602 STELLARIS VISION ENHANCEMENT SYSTEM UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5110 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other B+L STELLARIS SYSTEM.