BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 4828000 · Received June 9, 2015

    Report

    Report Number
    9614546-2015-00134
    Event Type
    Injury
    Date Received
    June 9, 2015
    Date of Event
    January 1, 2015
    Report Date
    May 12, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND STATED THE PATIENT'S VISUAL ACUITY POST OPERATIVE WAS 0.9 IN BOTH EYES. THE PATIENT COMPLAINED THAT THE RIGHT EYE WAS MORE BLURRY. MEDICATIONS USED BY THE PATIENT WERE PRED FORT AND WERE USED (PRESCRIBED) AFTER NOTICING THE MEMBRANE, BUT THERE WAS NO INFLAMMATORY SIGNAL IN THE ANTERIOR SEGMENT. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. THERE WERE NO NON CONFORMANCES WITH RESPECT TO THE FINAL PRODUCT RELEASE PROCESS. THERE WERE NO ASSOCIATED NONCONFORMITY REPORTS OR DEVIATIONS. THERE WERE NO PROCESS AND/OR MATERIAL CHANGES WITHIN THE PRODUCTION ORDER. STERILIZATION BATCH WAS RELEASED 31-MAY-2013 AND THERE WERE NO NON CONFORMANCES WITH RESPECT TO THE STERILIZATION PROCESS. THE RESULTS OF COSMETIC INSPECTION PERFORMED AT FINAL INSPECTION WAS REVIEWED. THE IN-LINE OPTICAL INSPECTION DATA SHOWED THAT 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. THE PRODUCTION ORDER DID NOT SHOW ANY DEVIATION OR ASSIGNABLE CAUSE FOR THE COMPLAINT TYPE REPORTED OR WAS RELATED TO THE INITIAL REPORT INFORMATION. THE DOCUMENTATION SHOWED THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE DOCTOR REPORTED THE PROBLEM ON (B)(6) 2015. THE SPECIFIC DAY WAS NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE; LENS REMAINS IMPLANTED AT THE TIME OF SUBMITTING THE MDR. INITIAL REPORTER: PHONE NUMBER : (B)(6). (B)(4). THE MANUFACTURING RECORD REVIEW WAS PERFORMED. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THERE WERE NO PROCESS AND / OR MATERIAL CHANGES WITHIN THE PRODUCTION ORDER NUMBER. THERE WERE NO NONCONFORMANCES WITH RESPECT TO THE FINAL PRODUCT RELEASE PROCESS. THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THE APPEARANCE OF A FILAMENTOUS MEMBRANE STRIP ON THE FRONT SIDE OF THE INTRAOCULAR LENS MORE PRECISELY IN THE RING JUNCTION, ELEVEN MONTHS AFTER SURGERY. IT WAS STATED THAT BILATERAL LENS IMPLANTATION WAS PERFORMED ON (B)(6) 2014. IN (B)(6) 2015 THE PHYSICIAN NOTICED THE APPEARANCE OF THIN MEMBRANE, GRAYISH, FILAMENTOUS, WITH FREE INTERVALS IN BOTH EYES WITHOUT INFLAMMATORY REACTION AND POSTERIOR SURFACE WITHOUT OPACITIES. THE PHYSICIAN INFORMED THAT NO SURGICAL INTERVENTION WILL BE DONE. ADDITIONAL INFORMATION WAS REPORTED BY THE PHYSICIAN INDICATING THAT THERE WAS A REDUCTION OF VISUAL ACUITY COMMENTED BY THE PATIENT. AN EVALUATION THROUGH SLIT LAMP (BIOMICROSCOPE) WITH DILATED PUPILS WAS PERFORMED. THERE WAS NO INFLAMMATORY SIGNAL IN THE ANTERIOR SEGMENT. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE MEDICAL DEVICE REPORT WILL BE SUBMITTED FOR THIS PATIENT FOR EACH EYE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND STATED THE PATIENT''S VISUAL ACUITY POST OPERATIVE WAS 0.9 IN BOTH EYES. THE PATIENT COMPLAINED THAT THE RIGHT EYE WAS MORE BLURRY. MEDICATIONS USED BY THE PATIENT WERE PRED FORT AND WERE USED (PRESCRIBED) AFTER NOTICING THE MEMBRANE, BUT THERE WAS NO INFLAMMATORY SIGNAL IN THE ANTERIOR SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371152 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other