BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_TECNIS SYMFONY

    MDR report key: 11551883 · Received March 23, 2021

    Report

    Report Number
    9614546-2021-07100
    Event Type
    Injury
    Date Received
    March 23, 2021
    Report Date
    May 6, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: FURTHER INFORMATION WAS PROVIDED AND REPORTED AT 1-DAY POST-OPERATIVE (OP), PATIENTS' VISION SEEMS VERY CLOUDY. THERE WAS NO DISCOMFORT. VISUAL ACUITY (VA) OD: 20/60 -2 J-16. AT 2 DAYS POST-OP VA OKAY AND NOT AS GOOD PATIENT WOULD LIKE. THERE WAS NO PAIN OR DISCOMFORT. VA OD: 20/20 -1 J3, BEST CORRECTED VISUAL ACUITY (BCVA): 20/20, MANIFEST REFRACTION OD: +0.50 SPHERE. AT 2 WEEKS POST-OP, VA OKAY, NOT AS CLEAR AS EXPECTED. HALOS/RINGS/CIRCLES AROUND LIGHTS. VA OD: 20/20 -2, PL +0.25 X 095, BCVA: 20/20 -1. PATIENT EXPERIENCING SIGNIFICANT ISSUES WITH HALOS/GLARE. AT 1-MONTH POST-OP, GLARE/HALOS ARE ONGOING-BOTHERSOME- BUT AT NIGHT. OD NEAR VISUAL ACUITY (NVA) GOOD. PATIENT HAS RARE FLOATERS-THAT ARE TINY AND ONGOING. PATIENT HAS NO DISCOMFORT. VA OD: 20/20 -1. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION: SECTION D10: DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: 4/15/2021 SECTION H3: DEVICE RETURNED TO MANUFACTURER ¿ YES DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS AND THAT THE LENS WAS RECEIVED CUT IN PIECES, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. A SEARCH OF COMPLAINTS REVEALED TWO OTHER COMPLAINTS WERE RECEIVED UNDER THIS PRODUCTION ORDER; HOWEVER, THEY COULD NOT BE CONFIRMED; THEREFORE, NO ESCALATIONS WERE REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: FURTHER INFORMATION WAS PROVIDED THAT SURGERY WAS SUCCESSFULLY COMPLETED USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED THE CURRENT PATIENT STATUS IS UNKNOWN. THROUGH FOLLOW-UP THE SERIAL NUMBER AND MODEL NUMBER OF THE DEVICE WAS PROVIDED ALONG WITH THE GENDER AND DATE OF BIRTH OF THE PATIENT, IMPLANT AND EXPLANT DATES. THEREFORE, THE FOLLOWING FIELDS THAT WERE PREVIOUSLY REPORTED AS UNKNOWN HAVE NOW BEEN UPDATED ACCORDINGLY. SECTION A3: SEX/GENDER: MALE. SECTION A2: AGE/DATE OF BIRTH: ON (B)(6) 1951. SECTION D4: MODEL NUMBER: ZXR00. SECTION D4: CATALOG NUMBER: ZXR00U0195. SECTION D4: SERIAL NUMBER: (B)(6). SECTION D4: EXPIRATION DATE: DEC 7, 2023. SECTION D4: UDI NUMBER: (B)(4). SECTION D6A: IF IMPLANTED; GIVE DATE: ON (B)(6) 2020. SECTION D6B: IF EXPLANTED; GIVE DATE: ON (B)(6) 2021. SECTION H4: DATE MANUFACTURE DATE: DEC 7, 2018. SECTION H6: HEALTH EFFECT- IMPACT CODE: 4629 TO CAPTURE EXPLANT/EXCHANGE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510(K) #: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD GLARE/HALO WITH AN INTRAOCULAR LENS (IOL). THEREFORE, THE PATIENT WILL BE HAVING AN IOL EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454792 UNK_TECNIS SYMFONY POE AMO MANUFACTURING NETHERLANDS ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention