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 Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided; best estimate is between (b)(6) 2019.(b)(4).Attempts have been made to obtain additional information; however, to date a response has not been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxr00 21.0 diopter intraocular lens was implanted in the patient's right (od) eye on (b)(6) 2019.It was later explanted on (b)(6) 2019 due to unspecified injury.No complications have been reported post operatively.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site; therefore, the complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed one (1) additional investigation request received for this production order number, but it was not related to the reported event.Conclusion: as a result of the investigation, there is no indication of a quality product 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
Additional information: device available for evaluation, returned to manufacturer on: 10/08/2019.Device evaluation: the product was returned to the manufacturing site.A visual inspection was performed to the unit received and the following were the observations: particles/fibers were overserved in the lens surface (the iol was handled).The lens was cut, and some marks (depressions) were in the lens body.The two haptics were present and looks in good conditions, some viscoelastic present.There was no details of the explant reported.A complaint and product deficiency could not be determined.Conclusion: as a result of the investigation there is no indication of a quality product 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 (b)(4) 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: 9159414
• Report Number: 2648035-2019-01076
• Device Sequence Number: 2151803
• Product Code: POE
• UDI-Device Identifier: 05050474579118
• UDI-Public: (01)05050474579118(17)231213
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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: 12/13/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/08/2019; 10/17/2019; 10/25/2020
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 10/14/2019; 10/26/2019; 11/10/2020
• 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