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); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.If explanted; give date: the explant was scheduled for (b)(6) 2019.To date, no confirmation has been received.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the zxt375 multifocal iol (intraocular lens) was implanted on (b)(6) 2018 in the patient's right eye (od).Reportedly, the lens was planned to be explanted on (b)(6) 2019.The reason of the explant is unknown, not provided.No additional information was provided.
Additional Manufacturer Narrative
Additional information received indicated that the lens was explanted on (b)(6) 2019 as the patient had dysphotopsia and significant glare.It was indicated that the patient doing fine and has no post operation issues.The following fields were updated accordingly: if explanted, give date: (b)(6) 2019.Patient code 3191 - updated planned explant to explant.Additional patient code 3191 - glare.Additional patient code 2140 - dysphotopsia.Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be confirmed.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.A search in complaints history revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency and the reported complaint could not be confirmed.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 (b)(4) 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: 8469261
• Report Number: 9614546-2019-00284
• Device Sequence Number: 1781222
• Product Code: POE
• UDI-Device Identifier: 05050474606975
• UDI-Public: (01)05050474606975(17)220414
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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: 04/14/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U200
• 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: 03/06/2019
• Supplement Date Received by Manufacturer: 04/10/2019; 10/25/2020
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/09/2019; 11/11/2020
• 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: Required Intervention
• Date Report Sent to FDA: 01/01/2005