BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 7110918 · Received December 12, 2017

    Report

    Report Number
    9614546-2017-01220
    Event Type
    Injury
    Date Received
    December 12, 2017
    Report Date
    May 11, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    UDI-DI
    05050474536159
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION REPORTED BY AN OPTOMETRIST PROVIDED THE FOLLOWING: IT IS STILL UNKNOWN IF THE VISUAL ACUITIES PROVIDED OF 0.5 (20/40) AND 0.6 (20/33) ARE UNCORRECTED OR BEST CORRECTED VISUAL ACUITIES. REPORTEDLY, THERE WERE TWO POST-OPERATIVE REFRACTIONS PROVIDED: 0.50 X ¿1.00 X 100 [SEQ 0.00] ¿ DISTANCE AND 1.00 X ¿1.00 X 100 [SEQ +0.50] ¿ NEAR. A 17.0 DIOPTER LENS WAS IMPLANTED, AND PER THE CALCULATIONS, A 17.0 DIOPTER LENS SHOULD HAVE YIELDED AN SEQ NEAR -0.38. IT APPEARS A REASONABLE IOL POWER WAS IMPLANTED. THE AMOUNT OF RESIDUAL ASTIGMATISM PRESENT CAN BE DIRECTLY CORRELATED TO THE AMOUNT OF PRE-OPERATIVE CORNEAL CYLINDER. NOTE, IMPLANTING WITH A TECNIS MULTIFOCAL WILL NOT CORRECT FOR ANY ASTIGMATISM AND ANY REMAINING ASTIGMATISM WILL RESULT IN DECREASED VISUAL ACUITY. ADDITIONALLY, SLIT LAMP IMAGES THAT WERE PROVIDED WITH THE PATIENT DATA. THERE ARE FOUR IMAGES AND THE BOTTOM RIGHT IMAGE IS A PRE-OPERATIVE IMAGE AS IT INDICATES A CATARACTOUS LENS. PLEASE NOTE THE TOP RIGHT AND BOTTOM LEFT IMAGES APPEAR TO SHOW A MONOFOCAL IOL, NOT A MULTIFOCAL IOL AS YOU SAY WAS IMPLANTED (ZMB00). THE ZMB00 IOL SHOULD HAVE DIFFRACTIVE RINGS THAT ARE VISIBLE THROUGH THE SLIT LAMP EXAMINATION AND THESE TWO IMAGES DO NOT APPEAR TO SHOW ANY RINGS. ALSO, THERE APPEARS TO BE SOME TYPE OF OPACITY IN THE TOP RIGHT IMAGE; HOWEVER, IT CANNOT BE CONCLUDED WITH ANY CERTAINTY WHAT TYPE OF OPACITY IS PRESENT BASED OFF THE PHOTO. NO ADDITIONAL INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 12/1/2017. DEVICE RETURNED TO MANUFACTURER? YES. THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION WITH THE UNAIDED EYE SHOWS THE PRODUCT IS CUT IN PIECES, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. CONSIDERING THE CONDITION OF THE LENS ADDITIONAL ANALYSIS IS NOT POSSIBLE. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS WERE REVIEWED AND THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS HISTORY REVEALED NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCT ORDER NUMBER TO DATE. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN (B)(6) 2017. (B)(6). EXPLANT. UNEXPECTED POST-OPERATIVE REFRACTION. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZMB00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. AROUND A MONTH AFTER SURGERY, THE PATIENT'S VISUAL ACUITY WAS AROUND 0.5 (20/40) OR 0.6 (20/33) ON BOTH NEAR VISION AND FAR VISION. THEREFORE, THE DOCTOR DECIDED TO EXPLANT THE LENS ON (B)(6) 2017, AND REPLACE IT WITH A SINGLE VISION NON-AMO LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886926 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00 05050474536159

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention