BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 6323793 · Received February 10, 2017

    Report

    Report Number
    9614546-2017-00097
    Event Type
    Injury
    Date Received
    February 10, 2017
    Report Date
    April 10, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED COMPLAINT WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THROUGH FOLLOW UP IT WAS LEARNED THE ORIGINAL IMPLANT DATE TOOK PLACE ON (B)(6) 2016. THE CUSTOMER ALSO STATED THAT THE PATIENT WAS STILL EXPERIENCING VISUAL ISSUES DURING HIS RECENT FOLLOW-UP VISIT. FURTHERMORE, THE PHYSICIAN SUGGESTED PATIENT SHOULD LOOK FOR ANOTHER DOCTOR TO PERFORM THE EXPLANT. THE CUSTOMER DID NOT HAVE FURTHER INFORMATION IF THE PATIENT HAD THE LENS EXPLANTED. AGE/DATE OF BIRTH: (B)(6) 1952. SERIAL NUMBER#: (B)(4), CATALOG #: ZXR00U0185, EXPIRATION DATE #: 11/11/20121, UDI #: (B)(4). IMPLANT DATE: IF IMPLANTED, GIVE DATE: (B)(6) 2016. MFG DATE: DEVICE MANUFACTURING DATE: 11/11/2016. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, WAS NOT PROVIDED. DATE OF EVENT: UNKNOWN. SERIAL #: UNKNOWN/NOT PROVIDED. A COMPLETE CATALOG # IS UNKNOWN AS SERIAL NUMBER IS UNKNOWN. EXPIRATION DATE AND UDI # ARE UNKNOWN AS SERIAL NUMBER IS UNKNOWN. IF IMPLANTED, GIVE DATE: UNKNOWN/ NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. DEVICE MANUFACTURE DATE: UNKNOWN, AS SERIAL NUMBER IS UNKNOWN. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 30 DAYS POST OP, THE PATIENT WAS SEEING WELL BUT WAS NOT HAPPY WITH HALO AND GLARE. THE PHYSICIAN RECEIVED A LETTER FROM THE PATIENT DESCRIBING THE PATIENT'S SYMPTOMS. ACCORDING TO THE PATIENT, FOLLOWING HIS CATARACT SURGERY IN HIS LEFT EYE, HE NOTICED AN IMMEDIATE POSITIVE DIFFERENCE IN COLOR HUES, BUT CONTINUES TO EXPERIENCE UNIQUE AND "CHANGING" HALO EFFECTS, ESPECIALLY IN LOW LIGHT, NIGHT TIME AND DRIVING SITUATIONS. WHEN DRIVING THE PATIENT OBSERVE A STARBURST AND COTTON BALL HALO AFFECT EMANATING FROM EACH ONCOMING HEADLIGHT THAT APPEARS AS A DUAL HALO WITH A STARBURST EFFECT. THE PATIENT STATED THAT THE IMPLANT RESULTED IN A STRONG STARBURST AT NIGHT AND HALO EFFECT THAT IS A STRONG NEGATIVE AND IS AFFECTING HIS DRIVING ABILITY AT NIGHT. ACCORDING TO THE PHYSICIAN, THE PATIENT IS 20/25 J2, BUT THE PHYSICIAN IS CONSIDERING EXPLANTING THE LENS. THE PHYSICIAN NOTED THAT THERE IS SOME MILD SMUDGE ON THE CAPSULE BUT DOES NOT THINK ITS CONTRIBUTING TO THE SYMPTOMS. THROUGH FOLLOW-UP WE LEARNED THAT THE PATIENT¿S VISUAL ACUITY IS GREAT. THE PHYSICIAN NOTED THAT PATIENT'S PUPIL TO BE A LITTLE LARGE AND WILL BE GIVING THE PATIENT ALPHAGAN AND NATURAL TEARS TO DECREASE THE SYMPTOMS. PATIENT IS SCHEDULED TO SEE ANOTHER DOCTOR IN THE AREA NEXT MONTH. THEY WILL WAIT AND SEE WHAT THE OTHER DOCTOR SUGGESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105404 TECNIS SYMFONY MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other