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	Visual Disturbances (2140); No Code Available (3191)
Date of Event	05/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: n/a; to date the lens remains implanted.(b)(4).Device evaluation: product testing could not be performed since the device was not returned for evaluation as it remains implanted.The customer's reported complaint could not be verified.Manufacturing records evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search of complaints revealed that no similar complaints for this production order number have been received.The directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.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 at the 3-month study visit, the patient reported being moderately bothered by poor low light vision when reading.Visual acuity: j1 right eye (od); j1 left eye (os).Additional information received reported the uncorrected bilateral near vision was 20/25 at the 3-month visit.Best corrected monocular vision was 20/16 od and 20/12.5 os.At the 1-month study visit, the patient reported moderately bothered with visual symptoms (poor low light vision with significant difficulty reading at near and glare).The symptoms significantly interferes with daily activities.There are no plans for medical or surgical intervention.No additional information was received.This report is for the left eye.A separate mdr has been submitted for the right eye.
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: 8681076
• Report Number: 9614546-2019-00528
• Device Sequence Number: 2021431
• Product Code: POE
• UDI-Device Identifier: 05050474605237
• UDI-Public: (01)05050474605237(17)211221
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020
• 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: 12/21/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U215
• 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: 05/13/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 11/12/2020
• 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
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005