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

Model Number	ZXT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens remains implanted.Facility name: unknown/not provided.(b)(4).Device evaluation: product testing could not be performed because the product was not returned.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.The search revealed that no similar complaints were received for this production order number.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.
Event or Problem Description
It was reported that a patient included in a clinical study has bilateral zxt375 intraocular lenses (iols) implants.At the 4th month visit, the patient complained of being moderately bothered by halos, multiple/double vision, sensitivity to light, glare, poor low light vision, difficulty driving at night, and reading.There is no planned intervention.Visual acuity (va) for both eyes (ou) 20/20.Implant date for left eye (os) is (b)(6) 2019, and implant date for right eye (od) is (b)(6) 2019.It was learned that at the 3-month study visit the patient reported some bother with visual symptoms, but did not affect his daily living.However, at the 4th month visit, the preoperative monocular best corrected distance visual acuities (bcdvas) were od 20/25 and os 20/25, so the drop is one line from the preop visit.In addition, there was a diagnosis of epiretinal membrane (erm) in the left eye at the 4-month visit, which the site believes contributed to the lower-than-expected visual acuity in this eye.The subject reported that the visual symptoms did significantly interfere with her daily activities, and mentioned driving and reading in the patient reported visual symptom questionnaire (prvsq).No other information was provided.This mdr report pertains to the right (od).A separate report will be submitted for the left eye (os).
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
• MDR Report Key: 9236626
• Report Number: 9614546-2019-00994
• Device Sequence Number: 11174149
• Product Code: MFK
• UDI-Device Identifier: 05050474606968
• UDI-Public: (01)05050474606968(17)210810
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020
• Report Date (Section F): 01/01/2005

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: 08/10/2021
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005