BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 5496406 · Received March 11, 2016

    Report

    Report Number
    9614546-2016-00105
    Event Type
    Injury
    Date Received
    March 11, 2016
    Report Date
    November 8, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI #:UNKNOWN, BECAUSE PRODUCT DETAILS ARE NOT AVAILABLE. PT AGES/DATES OF BIRTH: UNKNOWN. PT GENDERS/SEXES: UNKNOWN. DATES OF EVENT: UNKNOWN. SERIAL #''S, EXPIRATION DATES: UNKNOWN. IMPLANT AND EXPLANT DATES: IF IMPLANTED; GIVE DATES: UNKNOWN. INITIAL REPORTER TELEPHONE NUMBER: UNKNOWN. ADDITIONAL REPORTER: (B)(6). HEALTH PROFESSIONAL: YES. OCCUPATION: PHYSICIAN. (B)(4). DEVICE MANUFACTURE DATES: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE MULTIFOCAL INTRAOCULAR LENSES REPORTED IN THE JOURNAL ARTICLE WERE NOT RETURNED TO THE MANUFACTURING SITE. AN INVESTIGATION, THEREFORE, WAS NOT POSSIBLE AND THE REPORTED EVENTS COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS SERIAL NUMBERS WERE NOT PROVIDED FOR THE REPORTED EVENTS. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) FOR MULTIFOCAL LENSES WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE INTRAOCULAR LENSES. THE DFU PROVIDES INFORMATION ON ADVERSE EVENTS TO INCLUDE COMPLICATIONS THAT MAY OCCUR FOLLOWING IMPLANT SUCH AS VISUAL QUALITY UNDER CERTAIN LIGHTING, HAZE, DIPLOPIA, POOR STEREOPSIS. SOME OPTICAL EFFECTS MAY BE MITIGATED UPON THE PATENT'S ADAPTION TO THE LENS. HOWEVER, SOME COMPLICATIONS MAY REQUIRE SECONDARY SURGICAL INTERVENTIONS FOR EXCHANGE/EXPLANT. BASED ON THE INVESTIGATION RESULTS, NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    JOURNAL ARTICLE: A REVIEW OF THE SURGICAL OPTIONS FOR THE CORRECTION OF PRESBYOPIA: GIL-CAZORLA R, ET AL. BR J OPHTHALMOL 2015;0:1-9. DOI:10.1136/BJOPHTHALMOL-2015-306663. PAGE 5 PACKER ET AL TECNIS MULTIFOCAL (TCMF) 1 YEAR, 244 EYES. 95.5% SPECTACLE INDEPENDENCY FOR DISTANCE VISION. 86.6% SPECTACLE INDEPENDENCY FOR NEAR VISION. 94.6% SATISFIED. 10.3% PATIENTS REPORTED MODERATE GLARE. 2.6% PATIENTS REPORTED SEVER GLARE. 1 PUPILLOPLASTY. 4 IOL EXPLANTATION. 12.8% EYES REQUIRED YAG LASER. EVALUATION OF THE ASPHERIC TECNIS MULTIFOCAL INTRAOCULAR LENS: ONE-YEAR RESULTS FROM THE FIRST COHORT OF THE FOOD AND DRUG ADMINISTRATION CLINICAL TRIAL: AM J OPHTHALMOL 2010;149:577-584. 2010 BY ELSEVIER INC. PAGE 577 PURPOSE: TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE ASPHERIC DIFFRACTIVE TECNIS MULTIFOCAL ZM900 (TCMF) INTRAOCULAR LENS (IOL; ABBOTT MEDICAL OPTICS, INC., (B)(4). SUBJECTS UNDERWENT BILATERAL IMPLANTATION WITH THE TCMF IOL OR THE CEEON 911A MONOFOCAL (CEMN) IOL (ABBOTT MEDICAL OPTICS, INC) ACCORDING TO SUBJECT PREFERENCE. RESULTS: ONE-YEAR RESULTS WERE AVAILABLE FOR 244 EYES OF 125 TCMF IOL SUBJECTS AND FOR 245 EYES OF 123 CEMN IOL SUBJECTS. MEAN DISTANCE VISUAL ACUITIES (VAS) WERE STATISTICALLY AND CLINICALLY EQUIVALENT BETWEEN THE 2 GROUPS. PAGE 579 RESULTS: ONE-YEAR DATA AS OF FEBRUARY 27, 2007, WERE AVAILABLE FROM 94.4% (118/125) OF TCMF IOL SUBJECTS. SEVEN TCMF IOL SUBJECTS WERE NOT INCLUDED IN THIS ANALYSIS BECAUSE OF DECLINING TO PARTICIPATE FURTHER (N=2), LENS EXPLANTATION (N=1), DEATH (N=1), LOSS TO FOLLOW-UP (N=1), AND LACK OF 1 YEAR BILATERAL DATA BECAUSE OF DELAYED IMPLANTATION OF THE SECOND EYE (N=2). ADDITIONAL SURGICAL PROCEDURES OR COMPLICATIONS WERE RARE FOR EITHER LENS GROUP. THERE WERE 3 LENS-RELATED SECONDARY SURGICAL INTERVENTIONS IN A SINGLE TCMF SUBJECT WHO UNDERWENT A PUPILLOPLASTY AND BILATERAL LENS EXPLANTATION. IN THIS SUBJECT, THERE WAS A MISALIGNMENT OF LESS THAN 0.5 MM BETWEEN THE IOL AND THE DILATED PUPIL BECAUSE OF A SLIGHT DIFFERENCE IN ANATOMIC POSITION. PUPILLOPLASTY WAS UNDERTAKEN IN 1 EYE IN AN EFFORT TO ALLEVIATE HALOS AND GLARE, BUT ULTIMATELY BOTH EYES UNDERWENT LENS EXCHANGE FOR A MONOFOCAL IOL. FOUR LENSES WERE EXCHANGED IN THE TCMF IOL GROUP: 3 BECAUSE OF ERRORS IN REFRACTIVE POWER, AND 1 BECAUSE OF IMPLANTATION OF AN INCORRECT LENS. PAGE 581 FOR EACH EYE, SUBJECTS WERE ASKED BY INVESTIGATORS IF THEY WERE HAVING ANY DIFFICULTIES WITH THEIR VISION. AT 1 YEAR, NIGHT GLARE (15.5% [18/116]) AND HALOS (22.4% [26/116]) WERE THE MOST FREQUENTLY REPORTED SYMPTOMS FOR THE TCMF IOL GROUP (FIRST EYE). MOST REPORTS OF NIGHT GLARE WERE MODERATE (10.3% [12/116]), AND ONLY 2.6% (3/116) WERE SEVERE. MOST HALOS WERE RATED AS MILD (12.1% [14/116]), WITH 5.2% (6/116) REPORTED AS MODERATE AND 5.2% (6/116) REPORTED AS SEVERE. PAGE 582 THE MULTIFOCAL IOL GROUP REPORTED MORE VISUAL SYMPTOMS, PARTICULARLY HALOS AND NIGHT GLARE, THAN THOSE WHO RECEIVED MONOFOCAL IOLS. MOST NIGHTTIME SYMPTOMS IN TCMF EYES GENERALLY WERE RATED AS MILD TO MODERATE AND DECREASED OVER THE DURATION OF THE TRIAL; HOWEVER, IN 1 TCMF SUBJECT, BILATERAL LENS EXCHANGE WAS NECESSARY BECAUSE OF SEVERE HALOS AND GLARE. OVERALL, MOST SYMPTOMS WERE RATED IN THE MILD TO MODERATE RANGE AND DECREASED OVER THE DURATION OF THE TRIAL. THE HIGH SUBJECT SATISFACTION RATINGS FOR THE TCMF IOL GROUP SUGGEST THAT THE VISUAL SYMPTOMS DID NOT INTERFERE WITH EVERYDAY ACTIVITIES. PAGE 583 IN SUMMARY, THE TCMF IOL PROVIDED SUBJECTS WITH SIGNIFICANTLY ENHANCED NEAR VISION WITHOUT SIGNIFICANT LOSS OF DISTANCE VISUAL FUNCTION COMPARED WITH A MONOFOCAL IOL. ALTHOUGH A SLIGHT DECREASE IN CONTRAST SENSITIVITY AND AN INCREASE IN PHOTIC PHENOMENA WERE NOTED WITH THE TCMF IOL, SUBJECT SATISFACTION WAS VERY HIGH FOR THE LENS, LIKELY A RESULT OF IMPROVED READING ABILITY, THE LOW INCIDENCE OF SPECTACLE WEAR, AND THE LARGE RANGE OF DEPTH OF FOCUS PROVIDED BY THE ASPHERIC TCMF IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151216 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZM900

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R