MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS SYMFONY TORIC; MULTIFOCAL IOLS

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: if explanted, give date: not applicable, as the intraocular lens remains implanted in the patient's ocular dexter (right eye).Facility name: not applicable, as the patient reported the event.It was indicated that the iol is not being returned for evaluation as it remains implanted in the patient's ocular dexter (right eye).Therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye) (b)(6) 2020.Patient reports that she never had clear vision after her surgery, and stated her vision is blurred up to 27 inches in front of her.She was assured she would have mid-range vision and she does not.She has not been able to read labels, see her phone, lemon seeds, etc.Since day of surgery.Distance vision is pretty good, but she still can¿t see signs at night when she is driving or anything close-up.Street signs are visible if she sits and focuses on them at stop signs, but not in the approaching distance or whirring by.She has tried 3 pairs of glasses in order to see with the following results: power of 3.25 allows her to see at precisely 10 inches.But not closer or farther.Power of 2.0 allows her to see ~2 feet with no midrange.Signs with smaller print than speed limits are blurry.Cannot see the signs, let alone words on them at night.Power 1.5 allows her to drive, but she can¿t read her phone with it.She has tried different contacts and this did not work either; cannot see labels with +.25 add high contact lens.She has used eye drops but it hasn¿t helped.Pre & post-operative drops are besivance, durezol/lotemax, prolenza, preservative free tears & xiidra to improve tear film.Also simbrinza drops were used during last 10 days of healing for reducing eye pressure.She saw her dr.Last a few weeks ago.She doesn¿t have a satisfactory outcome.No additional information was provided.
Additional Manufacturer Narrative
Section h-6 patient code: 1937 was reported in the initial report.However, upon further review the iop coding is not applicable because it is part of the normal practice to treat after an iol implant.There is no indication that the iop is higher then expected post-operatively.Section h-6 patient code: 2140 was added as the information was known at the time of the initial report, but inadvertently not included.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
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.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e. st. andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 10451346
• Report Number: 9614546-2020-00335
• Device Sequence Number: 11676358
• Product Code: POE
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 09/17/2020; 10/25/2020; 08/11/2026
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/22/2020; 10/29/2020; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BAUSCH+LOMB CAPSULAR TENSION RING
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Female