BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY IOL

    MDR report key: 12749597 · Received November 3, 2021

    Report

    Report Number
    2020664-2021-07979
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    July 10, 2020
    Report Date
    December 17, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474652583
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: IN THE INITIAL MDR, SECTION SECTION H6 -HEALTH EFFECT - CLINICAL CODE: 4581 WAS CAPTURED FOR POSTERIOR CAPSULAR OPACIFICATION, HOWEVER, IT WAS INADVERTENTLY NOT EXPLAINED IN SECTION H10. THEREFORE, IT IS BEING CAPTURED IN THIS SUPPLEMENTAL FILING. SECTION H6 -HEALTH EFFECT - CLINICAL CODE: 4581: POSTERIOR CAPSULAR OPACIFICATION. ADDITIONAL INFORMATION: FOLLOWING SURGERY, PATIENT (PX) FAILED TO NEUROADAPT TO THE LENSES. PATIENT WAS DIAGNOSED WITH POSTERIOR CAPSULAR OPACIFICATION (PCO) IN BOTH EYES ON (B)(6) 2020 (75 DAYS POST BILATERAL SURGERY). YAG LASER CAPSULOTOMY WAS PERFORMED ON (B)(6) 2021. PX¿S LAST APPOINTMENT WAS (B)(6) 2021. AT THAT APPOINTMENT, PX WAS WEARING SPECTACLES AND STRUGGLING WITH DISTANCE VISION. HER UNAIDED DISTANCE VISUAL ACUITIES WERE 6/10 IN THE RIGHT EYE AND 6/7.5 IN THE LEFT EYE. THE UNAIDED NEAR VISUAL ACUITY WAS MEASURED TO BE N8 IN THE RIGHT EYE AND N6 IN THE LEFT EYE. A MEDICAL EXPERT ON (B)(6) 2021 NOTED THAT PX STRUGGLES TO DRIVE AT NIGHT BECAUSE OF A COMBINATION OF HER VISION BEING HAZY, WITH POOR QUALITY OF VISION, BECAUSE OF SEVERE GLARE, SEVERE HALOS, AND SEVERE STARBURSTS, THEREFORE, SHE CANNOT READ ROAD SIGNS AT A DISTANCE AND HAS DIFFICULTY JUDGING DISTANCES ON THE ROAD, ESPECIALLY IN WET CONDITIONS. SHE CANNOT DRIVE ON UNLIT OR UNFAMILIAR ROADS AND ON OCCASIONS BECOMES DISORIENTATED. THIS DIFFICULTY WITH NIGHT DRIVING IS PROBLEMATIC, BECAUSE PATIENT REQUIRES TO CARE FOR HER VERY ELDERLY FATHER WHO LIVES ALONE. PX IS A PHARMACIST. SHE HAS DIFFICULTY READING SMALL PRINT WITHOUT EXTRA LIGHTS RIGHT ABOVE THE PRINT, DESPITE ADJUSTING HER READING DISTANCE. THIS CAUSES DIFFICULTIES IN DISPENSING MEDICATION, WHEN SHE MUST READ THE SMALL WRITING ON MEDICATION PACKAGES AND LABELS. PATIENT HAS DIFFICULTY WITH MANY EVERYDAY ACTIVITIES SUCH AS COOKING OR CHOPPING VEGETABLES WHEN SHE IS UNCERTAIN ABOUT JUDGING DISTANCES WITHOUT ADDITIONAL LIGHT, AND SHE HAS DIFFICULTY READING THE CONTROLS ON HER COOKER. SHE NEEDS TO USE A TABLE LAP WHEN EATING TO SEE THE FOOD ON HER PLATE. SHE HAS DIFFICULTY WITH HER HOBBY OF CYCLING AS PAVEMENTS AND TERRAIN AHEAD ARE UNCLEAR. PATIENT ANTICIPATES THAT HER VISION WILL NOT BE GOOD ENOUGH FOR HER HOBBY OF SKIING. PARTICIPATION IN SOCIAL ACTIVITIES IS RESTRICTED AS SHE CANNOT DRIVE AT NIGHT. SHE FINDS THAT SHE BUMPS INTO OBJECTS IN CONDITIONS OF REDUCED LIGHTING. AND SHE REQUIRES TO USE THE TORCH ON HER PHONE "ALL THE TIME". PRIOR TO SURGERY, SHE ADVISED OPTICAL EXPRESS THAT SHE SUFFERS FROM OBSESSIVE COMPULSIVE DISORDER (OCD). SHE HAS BEEN TAKING PROZAC FOR OCD FOR SIX OR SEVEN YEARS. SHE IS NOW REQUIRED TO WEAR GLASSES WITH A READING ADDITION OF +1.50 AS WELL AS DISTANCE SPECTACLES. THE MEDICAL EXPERT FOUND PX'S UNAIDED DISTANCE VISUAL ACUITIES TO BE RIGHT EYE 6/12 + 3 AND LEFT EYE 6/9. WITH UNAIDED NEAR VISUAL ACUITY THE RIGHT EYE IS N8 AND LEFT EYE N6. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    WEIGHT AND ETHNICITY: INFORMATION UNKNOWN/ NOT PROVIDED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE LENS REMAINS IMPLANTED. TELEPHONE NUMBER: (B)(6). THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO CATARACTS AND SOUGHT REFRACTIVE SURGERY IN ORDER TO DISPENSE WITH SPECTACLES. THE PATIENT REPORTS THAT AFTER SURGERY WITH AN INTRAOCULAR LENS (IOL), SHE WAS CONCERNED ABOUT THE LACK THE IMPROVEMENT AND CLARITY AFTER A FEW DAYS. SHE WAS TOLD FOR MANY WEEKS THAT IT WAS STILL HEALING AND TO KEEP USING EYE DROPS. AFTER SEVERAL WEEKS HER VISION KEPT DETERIORATING. THE PATIENT REPORTED THIS WAS BECAUSE OF PCO (POSTERIOR CAPSULE OPACIFICATION). THREE MONTHS AFTER SURGERY, THE PATIENT COULD NOT DRIVE BECAUSE OF BLURRED VISION AND STARBURSTS. THE PATIENT COULD NOT READ INSTRUCTIONS/COOK/PREPARE MEALS/DRIVE FOR HERSELF AND HER ELDERLY PARENTS. THE PATIENT HAD SEVERAL ACCIDENTS: BUMPING HER HEAD AND FALLING OFF HER BIKE BECAUSE SHE COULD NOT JUDGE DISTANCE. THE PATIENT WENT THE WRONG WAY ON A HIGHWAY DUE TO AN INABILITY TO READ SIGNS. AFTER THREE MONTHS, THE PATIENT HAD A CONVERSATION WITH THE HEALTHCARE PROVIDER WHERE HIS SUGGESTION WAS TO GET ANTI-GLARE GLASSES FROM AMAZON. THE PATIENT WAS ALSO GIVEN A SERIES OF DROPS AND CONTACT LENSES. PRIOR TO SURGERY, HER UNAIDED VISUAL ACUITY WAS 6/60 RIGHT LEFT AND BINOCULAR. HER INTERMEDIATE VISION WAS 6/30 RIGHT LEFT AND BINOCULAR. HER NEAR VISION WAS N6 RIGHT LEFT AND BINOCULAR. WITH AN APPROPRIATE PRESCRIPTION (RIGHT -3.25/-0.25X130, LEFT -3.50/-0.25X107 AND A NEAR ADDITION OF +1.00, SHE ACHIEVED BEST CORRECTED VISUAL ACUITY OF 6/5 RIGHT LEFT AND BINOCULAR AND N5 RIGHT, LEFT AND BINOCULAR. HER DOMINANT EYE WAS RECORDED AS BEING THE RIGHT EYE. HER AXIAL LENGTH IN THE RIGHT EYE WAS 24.85 AND LEFT EYE WAS 25.17. ONE DAY POST-OPERATIVELY (OP) UDVA (UNCORRECTED DISTANCE VISUAL ACUITY) WAS 6/10 RIGHT LEFT AND BINOCULARLY, AND UNVA (UNAIDED NEAR VISUAL ACUITY) WAS N5 RIGHT LEFT AND BINOCULARLY. THE PATIENT COMPLAINED OF SLIGHTLY BLURRED VISION AND LIGHT SENSITIVITY. SLIT LAMP FINDINGS WERE BILATERAL IRITIS AND MARKED CELLS IN THE RIGHT EYE. STEROID USE WAS INCREASED. THE PATIENT HAD AC (ANTERIOR CHAMBER) CELLS IN BOTH EYES IN (B)(6) 2020. THE PATIENT REPORTED THAT HER NEAR VISION WAS GOOD BUT HER DISTANCE VISION WAS SUCH THAT SHE WAS WORRIED SHE SHOULD NOT BE DRIVING. ON (B)(6) 2020 AT A POST-OP APPOINTMENT, THE PATIENT STATED THAT SHE WAS ¿UNHAPPY WITH DISTANCE VISION AND NEAR VISION STOPPED DROPS FRIDAY, COULD NOT LIVE LIKE THIS.¿ UDVA WAS 6/7.5+2 RIGHT, 6/7.5 LEFT AND BINOCULARLY. UIVA (UNCORRECTED INTERMEDIATE VISUAL ACUITY) WAS 6/20 RIGHT LEFT AND BINOCULARLY AND UNVA WAS N10 RIGHT LEFT AND BINOCULARLY. AC CELLS ARE NOTED ON SLIT LAMP EXAMINATION. MAXIDEX WAS PRESCRIBED. ON (B)(6) 2020, THE PATIENT REPORTED BLUR AND LACK OF SHARPNESS DISTANCE AND NEAR. UDVA WAS 6/7.5 RIGHT LEFT AND BINOCULARLY. UIVA WAS 6/19 RIGHT LEFT AND BINOCULARLY. UNVA WAS N10 RIGHT AND LEFT, N8 BINOCULARLY. WITH THE ADDITION OF A PRESCRIPTION IN EACH EYE, THE PATIENT ACHIEVED BCDVA (BEST CORRECTED DISTANCE VISUAL ACUITY) 6/5, BCIVA (BEST CORRECTED INTERMEDIATE VISUAL ACUITY) 6/15 AND BCNVA (BEST CORRECTED NEAR VISUAL ACUITY) N6, SO HER BCNVA WAS WORSE THAN PRIOR TO SURGERY. ON (B)(6) 2020 AT POST-OP REVIEW, THE PATIENT STATED ¿UNHAPPY WITH OUTCOME, VISION POOR AT NIGHT, NOT DRIVING, CAN SEE BUT NOT CLEAR.¿ ON (B)(6) 2020 THE PATIENT WAS FITTED WITH TORIC CONTACT LENSES. IT IS NOTED THAT THE PATIENT IS EXPERIENCING A LOT OF GLARE. DESPITE THE CONTACT LENSES IT WAS NOTED THAT THE PATIENT WAS STILL VERY AWARE OF THE OVERALL LACK OF SHARPNESS AND DEFINITION AND HALOS CAUSING ISSUES WITH NIGHT DRIVING. IT WAS EXPLAINED THAT THE CONTACT LENS TRIAL WAS WITH A VIEW TO DECIDING WHETHER LASER ENHANCEMENT SURGERY WOULD BENEFIT THE PATIENT. IN (B)(6) 2020 IT WAS NOTED THAT THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY OF 6/5 IN EACH EYE WHICH WAS WORSE THAN HER PRE-OP VISION. HER BCNVA WAS N8 RIGHT EYE AND N6 LEFT EYE. IN (B)(6) 2021, SHE WAS NOTED TO HAVE CAPSULAR FOLDS IN BOTH EYES, THE LEFT BEING WORSE THAN THE RIGHT. THE PATIENT REPORTED HER VISION AS BEING LIKE "DIRTY SPECS." IN FEBRUARY OF THE SAME MONTH, A SLIT LAMP EXAMINATION OBSERVED PCO (POSTERIOR CAPSULAR OPACIFICATION) AND CRAZY PAVING APPEARANCE. BILATERAL YTTRIUM ALUMINUM GARNET (YAG) LASER CAPSULOTOMY WAS PERFORMED. VISUAL CLARITY IMPROVED, BUT THE PATIENT STILL REPORTED HALOS, POOR VISION IN LOW LIGHT, POOR NEAR VISION, AND DISTANCE VISION THAT NEEDS GLASSES. PROBLEMS WITH NIGHT DRIVING WERE REPORTED, AND IS NOT POSSIBLE OVER LONG DISTANCES. IN (B)(6) 2021 AT POST-OP REVIEW, IT WAS NOTED THAT THE PATIENTS UDVA 6/10 RIGHT AND 6/10 LEFT, BINOCULAR 6/7.5-2. UIVA IS 6/19 RIGHT, LEFT AND 6/15 BINOCULAR. UAVA NEAR IS N8 RIGHT LEFT AND BINOCULAR. THE LAST APPOINTMENT IN MAY INDICATED THAT UDVA WAS 6/10 RIGHT, 6/7.5 LEFT AND UNVA WAS RIGHT N8, LEFT N6. THE RIGHT EYE ACCORDINGLY HAS WORSE VISUAL ACUITY THAN PRE SURGERY. THE APPOINTMENT WAS TO DISCUSS SPECTACLES THE PATIENT WAS WEARING AND WHICH DID NOT HELP HER. THE PATIENT WAS UNHAPPY WITH THE QUALITY OF HER VISION AND WITH PHOTIC PHENOMENA FROM DAY ONE. NO INFORMATION REGARDING PRE-EXISTING OR CURRENT MEDICAL CONDITIONS IS CURRENTLY AVAILABLE. THERE IS NO INDICATION OF INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO VITRECTOMY OR DELAY IN PROCEDURE. THE YAG IS THE ONLY PROCEDURE PERFORMED TO DATE. THE PATIENT CONTINUES TO COMPLAIN OF POOR QUALITY VISION AND STARBURST, GLARE, AND HALOS THAT PRECLUDE HER FROM DRIVING. PATIENT HAD BILATERAL LENS IMPLANTS. THIS COMPLAINT IS IN RELATION TO THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645947 TECNIS SYNERGY IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZFR00V 05050474652583

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention