BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 5816942 · Received July 22, 2016

    Report

    Report Number
    9614546-2016-00355
    Event Type
    Injury
    Date Received
    July 22, 2016
    Report Date
    October 24, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: EXACT DATE UNKNOWN; WAS NOTED ONE WEEK POST OP THAT PATIENT NOT HAPPY WITH VISION CLARITY AND POSTERIOR CAPSULE OPACIFICATION. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LENS WAS INSPECTED USING 12X MAGNIFICATION. INVESTIGATION OF THE RETURNED LENS SHOWS THAT NO ANOMALIES WERE FOUND. THE LENS WAS EVALUATED BY RESEARCH AND DEVELOPMENT. ULTRA VIOLET, VISIBLE LIGHT AND NEAR INFRARED SPECTROSCOPY HAS BEEN DONE ON RETURNED SAMPLE. THE RESULT IS WITHIN SPECIFICATION AND THERE WAS NO EVIDENCE OF A MATERIAL DEGRADATION RELATED TO DISCOLORATION OR HAZE. MANUFACTURING RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. THERE WERE NO NON CONFORMANCES WITH RESPECT TO THE MANUFACTURING PROCESS. THERE WERE NO ASSOCIATED NONCONFORMITY REPORTS OR DEVIATIONS. RESULTS OF THE OPTICAL MEASUREMENT PERFORMED AT FINAL INSPECTION WERE REVIEWED. THE IN-LINE OPTICAL INSPECTION DATA SHOWS THE LENS WAS WITHIN POWER SPECIFICATION AND THE LENS MET THE SPECIFIED COSMETIC REQUIREMENTS. A SEARCH ON COMPLAINTS REVEALED THAT NO OTHER COMPLAINTS FOR THIS ORDER NUMBER WERE RECEIVED TO DATE. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE INTRAOCULAR LENSES. BASED ON THE INVESTIGATION RESULTS, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE CUSTOMER'S REPORTED EVENT COULD NOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S VISION WAS NEVER SATISFACTORY AFTER IMPLANTATION OF A ZLB00 INTRAOCULAR LENS (IOL) IN HER RIGHT EYE DUE TO POOR VISION. CUSTOMER REPORTED FOLLOWING RESULTS - PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) 20/30-1, 1+ NUCLEAR SCLEROSIS (NS) AND ANTERIOR CHAMBER (AC) CATARACT INTERFERING WITH ACTIVITIES OF DAILY LIVING. POST-OP 1 DAY UCVA 20/30 AND J2- AND 1+ PCO (INTEGRALLY HAZY CAPSULE S/P SILICONE IA POLISH INTRA-OP). POST-OP 1 WEEK 20/40 AND J1 UNCORRECTED VISUAL ACUITY (UCVA)/BCVA MX PLANO , NOT HAPPY WITH VISION CLARITY 1+ POSTERIOR CAPSULAR OPACIFICATION (PCO), RIGHT (OD). POST-OP 3 WEEKS 20/40+2 AND J3 UCVA W/ MANIFEST PLANO, NOT HAPPY WITH VISION. 1.5-2+ PCO OD. OPTICAL COHERENCE TOMOGRAPHY (OCT) MAC 6.14.16 WITHIN NORMAL LIMIT (WNL). REPORTEDLY, THERE WAS SOME INTEGRAL CAPSULAR HAZE INTRA-OP, WHICH EXPLAINS THE 1+PCO ON POD#1 DESPITE CAPSULE POLISHING WITH THE ALLEGRO SILICONE IA TIP. THE CHARACTER OF THE SUBOPTIMAL VISION AS WELL AS THE SNELLEN ACUITY HAS REMAINED RELATIVELY CONSTANT EVEN AS THE PCO HAS ESSENTIALLY DOUBLED IN DENSITY. THE PATIENT'S SYMPTOMS MAY SIMPLY BE HER INABILITY TO ADEQUATELY PROCESS/DIFFERENTIATE THE MULTIFOCAL IMAGES ON HER RETINA, EVEN THOUGH THE OTHER ETIOLOGY MIGHT BE THE PCO INTERACTION WITH THE MORE SENSITIVE DIFFRACTIVE OPTICS. INITIALLY, IT WAS REPORTED THAT THE DOCTOR PLANS TO EXCHANGE THE IOL TO A MONOFOCAL LENS WITH AN OPEN CAPSULE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE IOL WAS EXPLANTED WITH NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469481 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZLB00

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention