BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 5621548 · Received April 29, 2016

    Report

    Report Number
    9614546-2016-00202
    Event Type
    Injury
    Date Received
    April 29, 2016
    Date of Event
    April 4, 2016
    Report Date
    July 11, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN MDR FOLLOW-UP#1, DATE RECEIVED BY MANUFACTURER WAS ENTERED AS 05/09/2016. THE ACTUAL CORRECT DATE RECEIVED IS 05/06/2016. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT STATED THAT THE DATE OF LENS ROTATION WAS NOT PROVIDED, NOR THE DEGREE OF ROTATION. DURING A FOLLOW UP, IT WAS CONFIRMED THAT THE LENS WAS ROTATED ON (B)(6) 2016. THE ROTATION WAS ABOUT 15 TO 25 DEGREES. PATIENT WAS GREAT THE NEXT DAY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION AT THE TIME OF THIS REPORT THAT THE LENS HAS BEEN EXPLANTED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: TO DATE THE INTRAOCULAR LENS (IOL) REMAINS IMPLANTED; THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: SINCE THE SERIAL NUMBER IS UNKNOWN, A MANUFACTURING RECORDS REVIEW CANNOT BE PERFORMED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDE INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE WAS NOT VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 9.5 DIOPTER, ZCT450 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN PATIENT'S LEFT EYE. REPORTEDLY, THERE WAS SOME VISUAL IMPROVEMENT BUT THE IOL DID NOT CORRECT THE INTENDED AMOUNT OF ASTIGMATISM. CALCULATED ASTIGMATISM WAS 3.13 DIOPTER (D) AND POST-OP REFRACTION ON DAY 1 WAS -1.25 + 2.25 AT 115 DEGREES. PATIENT IS SCHEDULED FOR A SURGERY ON A RIGHT EYE WHERE CALCULATED ASTIGMATISM WAS 2.43D. IT WAS COMMENTED THAT TOPOGRAPHY PICKED UP MORE ASTIGMATISM THAN THE REFRACTION ON BOTH EYES. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS HAD ROTATED AND IT WAS ROTATED BACK, THE DATE WAS NOT PROVIDED, NOR THE DEGREE OF ROTATION. THERE WAS NO PROBLEM ONCE LENS WAS ROTATED BACK. THE PATIENT'S LONG EYE CONTRIBUTED TO LENS ROTATION. SECOND EYE HAD LENS IMPLANTED AS PLANNED WITHOUT ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277302 TECNIS TORIC IOLS HQL ABBOTT MEDICAL OPTICS ZCT450

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention