BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 5696495 · Received June 2, 2016

    Report

    Report Number
    2648035-2016-00848
    Event Type
    Injury
    Date Received
    June 2, 2016
    Report Date
    September 17, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED TO ABBOTT MEDICAL OPTICS FOR EVALUATION. HOWEVER, THE REPORTED ISSUE OF ¿DYSPHOTOPSIA¿ COULD NOT HAVE BEEN CONFIRMED FROM THE PRODUCT AS IT RELATES TO A PATIENT SYMPTOM. MANUFACTURING RECORDS REVIEW: NO SERIAL NUMBER WAS PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION AND REVIEW OF SIMILAR COMPLAINTS FOR THE ASSOCIATED PRODUCTION ORDER COULD NOT BE PERFORMED. LABELING REVIEW: ALTHOUGH THERE IS NO SERIAL NUMBER AND/OR PRODUCTION ORDER TO CONFIRM THE DIRECTIONS FOR USE (DFU) THAT WERE SENT OUT WITH THE LENS, THE CURRENT DFU WAS REVIEWED. THE DFU ADEQUATELY PROVIDE INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. CONCLUSION: THE REPORTED ISSUE WAS NOT VERIFIED. AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED IF EXPLANTED, GIVE DATE: DATE UNKNOWN BUT 43 WEEKS AFTER IMPLANT DATE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE ''SUCCESSFUL TREATMENT OF NEGATIVE DYSPHOTOPSIA WITH IN-THE-BAG INTRAOCULAR LENS EXCHANGE USING A WIDE OVOID IOL'' ARTICLE WAS REVIEWED. AUTHOR(S): KENNETH J. TAUBENSLAG, MD, ERICH B. GROOS, MD, MORGAN G. PARKER, MD, MARK D. EWALD, MD, R. DALE PILKINTON, MD. PUBLICATION: J CATARACT REFRACT SURG - VOL 42, FEBRUARY 2016. SCRS AND ESCRS PUBLISHED BY ELSEVIER INC. HTTP://DX.DOI.ORG/10.1016/J.JCRS.2016.01.012. NEGATIVE DYSPHOTOPSIA IS THE PERCEPTION OF A SHADOW, DARK ARC, OR CRESCENT IN THE TEMPORAL VISUAL FIELD FOLLOWING CATARACT SURGERY. OPTIONS FOR SURGICAL MANAGEMENT INCLUDE INTRAOCULAR LENS (IOL) EXCHANGE WITH INSERTION OF A REPLACEMENT IOL IN THE CILIARY SULCUS, REVERSE OPTIC CAPTURE, INSERTION OF A PIGGYBACK IOL, LASER ANTERIOR CAPSULOTOMY OR CAPSULECTOMY, AND IN-THE-BAG IOL EXCHANGE. THIS STUDY INVESTIGATED THE EFFICACY OF IN-THE BAG IOL EXCHANGE WITH AN OVERSIZED OVOID IOL TO MANAGE NEGATIVE DYSPHOTOPSIA. CASES WERE IDENTIFIED RETROSPECTIVELY FROM LOGS OF TWO SURGEONS IN SEPARATE PRIVATE PRACTICES. CASES WERE INCLUDED IF THE INDICATION FOR SURGERY WAS NEGATIVE DYSPHOTOPSIA, WHICH WAS DEFINED AS RECORDED COMPLAINTS OF PERSISTENT CURVED SHADOWS IN THE TEMPORAL VISUAL FIELDS FOLLOWING UNEVENTFUL CATARACT SURGERY IN EYES WITHOUT DETECTABLE VISUAL FIELD DEFECTS. ORIGINAL IOLS WERE EXPLANTED PER EACH SURGEON'S STANDARD PROTOCOL. A SINGLE-PIECE 5.75 MM 6.50 MM HYDROPHILIC ACRYLIC IOL WITH A SQUARE EDGED DESIGN (ANOTHER MANUFACTURER) WAS USED FOR THE BAG¿BAG EXCHANGES. IT WAS INJECTED COMPLETELY INTO THE CAPSULAR BAG AND ROTATED TO POSITION THE 6.50MM AXIS ALONG THE HORIZONTAL MERIDIAN. THERE WERE TEN CASES/EYES (PATIENTS (B)(6)) THAT MET THE INCLUSION CRITERIA. PATIENT (B)(6) HAD BOTH EYES AFFECTED. TWO OF THE TEN CASES (PATIENTS (B)(6)) INVOLVED LENSES FROM ANOTHER MANUFACTURER. THERE WILL BE A TOTAL OF SEVEN MDRS FILED FOR THE SEVEN PATIENTS. THIS MDR IS FOR PATIENT 4, A (B)(6) MALE PATIENT THAT HAD A MODEL Z9002 LENS EXPLANTED FROM HIS LEFT EYE 43 WEEKS AFTER IMPLANT. THE PATIENT HAD COMPLETE SYMPTOM IMPROVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349993 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention