BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 9924392 · Received April 3, 2020

    Report

    Report Number
    9614546-2020-00169
    Event Type
    Injury
    Date Received
    April 3, 2020
    Date of Event
    December 11, 2019
    Report Date
    January 8, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    UDI-DI
    05050474605688
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H6: PATIENT CODE 3191: DOUBLE VISION. SECTION H6: PATIENT CODE 3191: PHOTOPHOBIA. UPON FURTHER FOLLOW-UP IT WAS LEARNED THAT THE PATIENT IS THIS TIME MODERATELY BOTHERED BY HALOS- ¿BLUE HALO AROUND MOON AND STARS¿; VERY BOTHERED BY MULTIPLE OR DOUBLE VISION- ¿SEEING FAR AWAY¿; VERY BOTHERED BY SENSITIVITY TO LIGHT- ¿DRIVING-READING¿. YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY IS PLANNED FOR BOTH EYES, BUT HAS NOT YET BEEN SCHEDULED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER FOLLOW-UP, YTTRIUM-ALUMINUM GARNET (YAG) LASER, RIGHT EYE (OD) WAS PERFORMED. THE SUBJECT WAS SEEN FOR FOLLOW-UP AND STATED THEY WERE DOING WELL AND WERE HAPPY, VISUAL ACUITY (VA) WAS OD 20/20 UNCORRECTED. SECTION BELOW UPDATED. SECTION H6: PATIENT CODE: 3191: YAG. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. (B)(4). DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PREFORMED BECAUSE PER THE INITIAL REPORT THE LENS IS STILL IMPLANTED IN THE PATIENT'S EYE. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLINICAL STUDY PATIENT HAD BILATERAL TECNIS TORIC SYMFONY INTRAOCULAR LENSES (IOLS) IMPLANTED. THE SUBJECT AT A 1 MONTH VISIT REPORTED EXTREMELY THAT SHE WAS BOTHERED BY STARBURSTS WHILE DRIVING AND MODERATELY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT WHILE DRIVING. IN THE NON-DIRECTED OCULAR VISUAL SYMPTOMS THE SUBJECT COMPLAINED SEVERE STARBURSTS- BOTH EYES (OU). THE MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) ¿ RIGHT EYE (OD) 20/20; LEFT EYE (OS) 20/20. MONOCULAR BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) ¿ OD 20/15; OS 20/15. HOWEVER, FOR THE 6 MONTH VISIT REVEALED FINDINGS OF BCDVA: 20/20 OD; 20/15 OS, MEDICAL FINDINGS SIGNIFICANT FOR POSTERIOR CAPSULAR OPACIFICATION (PCO) OU, BUT THERE WAS NO YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY PLANNED. ALSO, THE SUBJECT REPORTED A COMPLAINT OF OCULAR VISUAL SYMPTOMS AS EXTREMELY BOTHERED BY STARBURSTS ¿ ¿DRIVE AT NIGHT¿; EXTREMELY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT- ¿DRIVE AT NIGHT¿. IN THE NON-DIRECTED OCULAR VISUAL SYMPTOMS THE SUBJECT COMPLAINED OF BLURRED VISION/DIFFICULTY WITH VISION- OVERALL AND NEAR; MILD HALOS; SEVERE STARBURSTS AND DIFFICULTY WITH VISION IN LOW LIGHT IN THE RIGHT EYE. THE SUBJECT DID STATE THE SYMPTOMS SIGNIFICANTLY IMPACTED DAILY ACTIVITIES. NEVERTHELESS, THERE WAS STILL NO INTERVENTION PLANNED. THIS MDR REPORT PERTAINS TO THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387473 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT225 05050474605688

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other