BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIGN TORIC POSTERIOR CHAMBER IOL

    MDR report key: 4846742 · Received June 12, 2015

    Report

    Report Number
    1313525-2015-01647
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    February 19, 2015
    Report Date
    May 13, 2015
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MJP
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE LENS IS IMPLANTED. THEREFORE, A PRODUCT EVALUATION COULD NOT BE CONDUCTED. ONE RETAIN SAMPLE FROM THE SAME LOT 7457815 WAS DIMENSIONALLY INSPECTED AND ALL MEASUREMENTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. BASED ON THE CURRENT INFORMATION, THE SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS TILTED APPROXIMATELY 6 WEEKS POST IMPLANT DUE TO CAPSULAR CONTRACTION. REPORTEDLY, THE PATIENT NOTICED A DECREASE IN VISION AND NEED A SECOND OPINION. THIS REPORT REFERS TO THE PATIENT'S RIGHT EYE. REFERENCE MDR# 1313525-2015-01648 FOR THE LENS INVOLVING THE PATIENT'S LEFT EYE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED DESCRIBES THE EVENT AS BILATERAL Z-SYNDROME WITH HIGH ASTIGMATISM POST CATARACT EXTRACTION AND IOL IMPLANTS. ACCORDING TO THE PHYSICIAN, THE LIKELY CAUSE OF THE EVENT WAS "ANTERIOR VAULTING OF OPTIC AT HINGE FOLLOWING CAPSULAR FIBROSIS AFTER ROUTINE CATARACT EXTRACTION AND BILATERAL IOL IMPLANT. THE PATIENT'S CURRENT PROGNOSIS AND TREATMENT IS "UNCLEAR IF LENS POSITION WILL CONTINUE TO CHANGE - TRYING CONSERVATIVE APPROACH WITH SPECTACLES FIRST ANS WILL RECHECK IN 3 WEEKS." PATIENT ALSO DEVELOPED CYSTOID MACULAR EDEMA (CME) OD AND SAW OUTSIDE RETINA DOCTOR. THE PATIENT WOULD PROBABLY BENEFIT FROM LENS EXCHANGE BUT THE PATIENT IS CONCERNED ABOUT ADDITIONAL COMPLICATIONS ESPECIALLY IN LIGHT OF CYSTOID MACULAR EDEMA (CME) OD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: REPORTEDLY, IT WAS DETERMINED THAT THE PATIENT'S VISION WAS BEING ADVERSELY AFFECTED BY TWO FACTORS. THE FIRST WAS ONSET OF "Z-SYNDROME" IN BOTH EYES, AND THE SECOND WAS THE SUDDEN AND UNEXPLAINED PRESENCE OF LEAKY CAPILLARY IN THE PATIENT'S RIGHT EYE. THE PATIENT HAS HAD MONTHLY INJECTIONS FOR ABOUT EIGHT MONTHS TO ADDRESS RETINAL BLEEDING FROM HIS RETINA SPECIALIST. REPORTEDLY, THE REFERRING DOCTOR HAS CONFIRMED THE PRESENCE OF Z-SYNDROME, AND HAS NOTED THE CONDITION IS MORE SEVERE IN THE RIGHT EYE. THE REFERRING DOCTOR IS EVALUATING TREATMENT OPTIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT: BLURRY VISION, MORE PREVALENT WITH DISTANCE AND MID-RANGE VISION. THE PATIENT INDICATED THAT IT HAS BEEN 4 MONTHS OF FLUCTUATING VISION AND IT IS STILL NOT RESOLVED. THE PATIENT IS NOW SEEING ANOTHER DOCTOR. REPORTEDLY, THE PATIENT WAS TOLD THAT THERE IS Z-SYNDROME AND IT IS HIGH RISK TO REMOVE THE LENSES. THE CURRENT DOCTOR HAD TREATED THE PROBLEM WITH CORRECTIVE LENSES (GLASSES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384132 TRULIGN TORIC POSTERIOR CHAMBER IOL LENS, INTRAOCULAR, TORIC OPTICS MJP BAUSCH + LOMB BL1UT 7457815

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other