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

Model Number	ZXR00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
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, but the best estimate date is during (b)(6) 2018.If explanted; give date: n/a.The lens remains implanted.The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient, who recently had cataract surgery on her both eyes (ou), developed a hyperopic surprise or unexpected post-op refraction after implanting zxr00 multifocal iol (intraocular lens) in her right eye (od).Moreover, patient was seeing glare and she reportedly saw rings in the center of the optic in certain light as she did not have ability to read.The doctor, however, advised the patient that these visual symptoms should dissipate as time goes on.No additional information provided.
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
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7821101
• Report Number: 9614546-2018-00819
• Device Sequence Number: 2434357
• Product Code: POE
• UDI-Device Identifier: 05050474591660
• UDI-Public: (01)05050474591660(17)230416
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0110
• 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: 07/30/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 11/02/2020
• 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: 68 YR
• Date Report Sent to FDA: 01/01/2005