BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 4846743 · Received June 12, 2015

    Report

    Report Number
    1313525-2015-01648
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    March 10, 2015
    Report Date
    May 13, 2015
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS IS IMPLANTED. THEREFORE, A PRODUCT EVALUATION COULD NOT BE CONDUCTED. ONE RETAIN SAMPLE FROM THE SAME LOT 7463214 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS TILTED APPROXIMATELY 6-7 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 LEFT EYE. REFERENCE MDR# 1313525-2015-01647 FOR THE LENS INVOLVING THE PATIENT'S RIGHT EYE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: REPORTEDLY, IT WAS DETERMINED THAT THE PATIENT'S VISION WAS BEING ADVERSELY AFFECTED THE ONSET OF "Z-SYNDROME". 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 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 FROM THE PT: BLURRY VISION, MORE PREVALENT WITH DISTANCE AND MID-RANGE VISION. THE PT INDICATED THAT IT HAS BEEN 4 MONTHS OF FLUCTUATING VISION AND IT IS STILL NO RESOLVED. THE PT IS NOW SEEING ANOTHER DOCTOR. REPORTEDLY, THE PT 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
    384264 CRYSTALENS ACCOMMODATING IOL LENS, INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB AT50AO 7463214

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other