BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5496968 · Received March 14, 2016

    Report

    Report Number
    9614546-2016-00106
    Event Type
    Injury
    Date Received
    March 14, 2016
    Report Date
    November 8, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLES DO NOT REPORT EXPLANTS. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR REPORT SHOULD HAVE ALSO BEEN INDICATED AS REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE INITIAL MDR REPORT REFLECTED AN INCORRECT MANUFACTURING REPORT #9614546-2016-00106, AND SHOULD HAVE REFLECTED A MANUFACTURING REPORT NUMBER OF 2648035. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    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 PATIENT'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

    A REVIEW OF 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 4 PHAKIC MIOL (B)(4) AL ALSO PERFORMED THE FIRST CLINICAL TRIAL WITH A TYPE OF MULTIFOCAL IOL IN 55 EYES SHOWING THAT THIS IOL WAS EFFECTIVE AND GAVE GOOD PREDICTABILITY. ALIO AND MULET, IN ANOTHER PILOT STUDY WITH A MULTIFOCAL PHAKIC IOL PROTOTYPE (AMO,(B)(4)) ALSO SHOWED GOOD RESULTS. HOWEVER, THE COMPLICATIONS REPORTED BY THESE ANTERIOR PHAKIC IOLS INCLUDING ENDOPHTHALMITIS, SURGICALLY INDUCED ASTIGMATISM, CORNEAL ENDOTHELIAL CELL LOSS, PUPIL DISTORTION, CHRONIC UVEITIS, PUPILLARY BLOCK GLAUCOMA, PIGMENT DISPERSION SYNDROME AND CATARACTS. PRESBYOPIA CORRECTION WITH AN ANTERIOR CHAMBER PHAKIC MULTIFOCAL INTRAOCULAR LENS: JORGE L. ALIO, MD, PHD, M. EMILIA MULET, MD, PHD OPHTHALMOLOGY 2005:112:1368-1374 2005 BY THE AMERICAN ACADEMY OF OPHTHALMOLOGY. PAGE 1368.E2 THE AMO MULTIFOCAL PHAKIC IOL PROTOTYPE (AMO, (B)(4)) IS A SINGLE-PIECE POLYMETHYL METHACRYLATE ANTERIOR CHAMBER IOL THAT IS DESIGNED TO MAXIMIZE THE PHYSICAL DISTANCE FROM THE IOL TO BOTH THE CORNEA AND THE IRIS. PAGE 1368.E4, 1368.E5 SUBJECTIVE REPORTS OF VISUAL SYMPTOMS CONSISTED OF 4 PATIENTS (23.4%) WITH HALOS: 3 PATIENTS (17.6%) WITH MILD HALOS AND MODERATE HALOS IN 1 PATIENT (5.88%); STAR BURSTS IN 2 PATIENTS (11.76%), AND GLARE IN 2 PATIENTS (11.76%). THERE WAS AN IMPROVEMENT IN STEREOPSIS BUT IT WAS NOT STATISTICALLY SIGNIFICANT. EFFICACY (VISUAL ACUITY) PATIENT SATISFACTION WAS EXAMINED USING AN EXTENSIVE QUESTIONNAIRE. SATISFACTION WAS REPORTED AS VERY GOOD (GOOD DISTANCE VISION AND ACCEPTABLE NEAR UNCORRECTED VISION) IN 15 OF THE 17 PATIENTS (88.2%), AND MODERATE IN THE REMAINING 2 PATIENTS (11.8%). NO PATIENTS REPORTED DISSATISFACTION. FOUR PATIENTS WHO DID NOT REACH UCNVA OF JAEGER 3 WERE PRESCRIBED GLASSES FOR NEAR VISION, AND 2 PATIENTS WHO REACHED JAEGER 3 WERE PRESCRIBED GLASSES TO ENHANCE NEAR VISION FURTHER. IN TOTAL, 65% OF PATIENTS DID NOT REQUIRE READING GLASSES. DESPITE CONCERNS, THE PATIENTS IN OUR STUDY DEMONSTRATED IMPROVED UNCORRECTED VA AT ALL DISTANCES. BINOCULAR UNCORRECTED DISTANCE VA IMPROVED FROM 20/59 BEFORE SURGERY TO 20/18 AT 1 YEAR AFTER IMPLANTATION, AND UNCORRECTED INTERMEDIATE VA IMPROVED FROM 20/125 TO 20/21, CONFIRMING THE EXTENDED DEPTH OF FOCUS THAT THIS IOL PROVIDES. ALSO, MEAN BINOCULAR UNCORRECTED NEAR VA IMPROVED FROM 20/78 TO 20/32, ALLOWING A READING LEVEL OF JAEGER 3 AND THE ABILITY TO CARRY OUT DAILY ACTIVITIES REQUIRING REASONABLE NEAR VISION (NEWSPAPERS, ETC.) WITHOUT ADDITIONAL CORRECTION. ALL THE PATIENTS IN THE STUDY ACHIEVED BINOCULAR DISTANCE AND INTERMEDIATE VA OF 20/40 AND NEAR VA OF JAEGER 5; 88.2% ACHIEVED 20/40 AND JAEGER 3. OUR FINDINGS CONCERNING ENDOTHELIAL CELL COUNT AND ANTERIOR SEGMENT COMPLICATIONS CORRELATE WITH SUCH REPORTS. OTHER AUTHORS HAVE OBTAINED SIMILAR REFRACTIVE RESULTS, ALTHOUGH INTERMEDIATE VISION WAS NOT EVALUATED. CONCERNING VISUAL SYMPTOMS, SOME PATIENT WITH POSTERIOR CHAMBER MULTIFOCAL IOLS HAVE EXPERIENCED OPTICAL VISUAL SYMPTOMS, PARTICULARLY AT NIGHT. PATIENTS MAY ALSO EXPERIENCE SUCH VISUAL SYMPTOMS WITH CONVENTIONAL GLASSES, ALTHOUGH THE INCIDENCE OF THESE EFFECTS HAS BEEN REPORTED TO BE HIGHER WITH MULTIFOCAL LENSES. IN OUR STUDY, ANY SUCH SYMPTOMS DISAPPEARED AT 1 TO 3 MONTHS AFTER SURGERY, EXCEPT IN 1 PATIENT WITH ANISOCORIA THAT WAS NOT RESPONSIVE TO MEDICATIONS. IN THIS PATIENT, THE SYMPTOMS WERE STILL PRESENT AT 6 MONTHS. PAGE 1368.E6 THERE WERE 4 CASES (11.7%) OF INFERIOR IOL DISPLACEMENTS RESULTING FROM SUBOPTIMAL IOL SIZE. THE SUBOPTIMAL FIT WAS CAUSED BY THE FACT THAT THE IOL WAS AVAILABLE ONLY IN 1 SIZE (12.5MM DIAMETER) FOR THE STUDY. THIS COMPLICATION WAS SOLVED WITH IOL ROTATION AND PLACEMENT IN THE NARROWER OR OBLIQUE DIAMETER OF THE EYE. THERE WERE 6 CASES OF TEMPORAL DISPLACEMENT (17.6%). FITTING COMPLICATIONS WILL BE OVERCOME WHEN DIFFERENT IOL SIZES BECOME AVAILABLE. ALTHOUGH THE VA OUTCOMES GENERALLY WERE EXCELLENT, 6 PATIENTS (6 EYES) REQUIRED ASTIGMATISM CORRECTION BY LASIK 6 MONTHS AFTER IOL IMPLANTATION. ALL PATIENTS WERE ABLE TO PERFORM NORMAL DAILY ACTIVITIES WITHOUT USING GLASSES IN DIFFERENT LIGHT CONDITIONS. THEIR RESPONSES REFLECT THE HIGH LEVEL OF SATISFACTION OF ALL THE PATIENTS INCLUDED IN THE STUDY IN DIFFERENT LIGHT CONDITIONS AND SITUATIONS. IN CONCLUSION, OUR PILOT STUDY INVESTIGATION DEMONSTRATED GOOD EFFICACY OUTCOMES AND DID NOT DETECT NOTABLE SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152957 UNKNOWN MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R