BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALANCED SALT SOLUTION

    MDR report key: 2731547 · Received September 6, 2012

    Report

    Report Number
    9614546-2012-00155
    Event Type
    Injury
    Date Received
    September 6, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 10, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF MANUFACTURING RECORD INDICATED THAT THE PRODUCT, ENDOSOL, MET SPECIFICATIONS PRIOR TO MANUFACTURING RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THE VITRECTOMY PROCEDURE PERFORMED IS BEING CORRECTED TO (B)(6) 2012. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PRIOR TO RELEASE TO MARKET, THE ENDOSOL MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED SAMPLES OF AMO ENDOSOL DEMONSTRATES THAT THE PRODUCT MET SPECIFICATIONS AND RELEASE REQUIREMENTS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR PERFORMED A VITRECTOMY PROCEDURE ON (B)(6) 2012, USING ENDOSOL, BALANCED SALT SOLUTION. IT WAS STATED THAT THE PATIENT PRESENTED WITH SWELLING AND TOXIC SYNDROME ON THE ANTERIOR SEGMENT OF THE EYE. IT WAS REPORTED BY THE DOCTOR THAT ENDOSOL WAS INVOLVED, ALTHOUGH THE DOCTOR DID NOT THINK THAT THE ENDOSOL IS THE REASON FOR THE ADVERSE EVENT. THE PATIENT WAS TREATED MEDICALLY AND REPORTEDLY RECOVERED. INITIALLY, THE DOCTOR REPORTED TO ABBOTT MEDICAL OPTICS (AMO) THAT THE PATIENT WAS OK; HOWEVER, IT WAS LATER REPORTED THAT THE PATIENT HAD A ''LOSS OF VISION AND A LONG RECOVERY PROCESS WITH SERIOUS RISK INVOLVED.'' NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF SUBMITTING THE MEDICAL DEVICE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALANCED SALT SOLUTION SURGICAL ADJUNCTS KIP ABBOTT MEDICAL OPTICS ENDOSOL 12C1203

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R