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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Halo (2227); No Code Available (3191)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens still remains implanted.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a customer has an upcoming intraocular lens (iol) exchange for a patient who had a symfony iol implanted in his left eye.It was learned that as the device has been implanted for more than a year now, the patient¿s visual issues significantly interferes with his regular activities, described as having difficulty seeing his bike¿s computer as well as having glares & halos.Also, the patient is unhappy with his near visual outcomes hence, the doctor plans to have it be replaced with a non-johnson and johnson iol.No other information was provided.
Additional Manufacturer Narrative
Information received that explant date was on (b)(6) 2020.The surgery went well.No incision enlargement, no vitrectomy, no sutures done.The suspect lens was discarded and will not be returned.Following sections updated: section d7: if explanted, give date: (b)(6) 2020.Device evaluation: product evaluation was not performed because according to the external communications, the product has been discarded.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed the product was manufactured and released according to specifications.A search revealed one additional complaint received is part of this production order, however, the complaint issue is a low risk and no investigation was required, therefore the complaint issue was not confirmed, and additionally, the complaint issue is not related to the complaint from the initial report.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.
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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10383096
• Report Number: 9614546-2020-00299
• Device Sequence Number: 19124557
• Product Code: MFK
• UDI-Device Identifier: 05050474579040
• UDI-Public: (01)05050474579040(17)230221
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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: 02/21/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0175
• 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: 07/15/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 10/25/2020
• Initial Report FDA Received Date: 08/09/2020
• Supplement Report FDA Received Date: 09/22/2020; 10/29/2020
• 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: 45 YR
• Date Report Sent to FDA: 01/01/2005