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 2/18/2020 and 3/2/2020.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxr00 intraocular lens (iol) was implanted in the patient's right (od) eye on (b)(6) 2020.It was later explanted on (b)(6) 2020 due to refractive miss.The patient has had two (2) multifocal lenses explanted from his right eye in two separate surgeries within a month.The surgeon decided to go with a non-johnson and johnson monofocal (single focus) lens.At exchange, there was no incision enlargement and no injury reported.No additional information was provided.This report captures the event for the second explanted lens.A separate report is being submitted for the first explanted lens.
Additional Manufacturer Narrative
Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 3/31/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the product was received in a plastic bag identified with patient stickers for the complaint and potentially the replacement lens (diopter but not the serial number was confirmed).Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during explant.Based on the return condition of the lens no product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency was identified.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 no other complaints have been received for this production order number.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 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: 9919207
• Report Number: 9614546-2020-00168
• Device Sequence Number: 3296746
• Product Code: POE
• UDI-Device Identifier: 05050474579149
• UDI-Public: (01)05050474579149(17)231030
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020
• 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: 10/30/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/10/2020; 10/25/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/11/2020; 10/30/2020
• 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