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)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient had complications after the implantation of +25.5 diopter lens model, zxr00 symfony multifocal iol (intraocular lens).For that reason, lens was explanted and replaced with +24.5 diopter lens with the same model, zxr00.No additional information provided.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the patient could not adapt to the distance vision, that the patient¿s symptoms first noted on (b)(6) 2019.It was noted that the patient was status post (s/p) lasik.There was no patient injury and no surgical interventions such as vitrectomy, incision enlargement or sutures were required as a result of this event.Reportedly, the patient was discharged without an issue.It was noted that the device was no longer available and it was discarded at the surgery center.The following fields have been updated accordingly: relevant history: post lasik.Date of birth: (b)(6).Corrected data: the date of event of ''(b)(6) 2019'' was entered in the initial emdr report; however, based on the new information received, the date of event has been corrected in the supplemental mdr report.The following field was updated accordingly: date of event: (b)(6) 2019 device evaluation: the product testing could not be performed as the product was not returned (the device was discarded at the surgery center).The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint history revealed no other complaint has been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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-(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: 8468115
• Report Number: 2648035-2019-00403
• Device Sequence Number: 1780609
• Product Code: POE
• UDI-Device Identifier: 05050474579200
• UDI-Public: (01)05050474579200(17)230712
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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: 07/12/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0255
• 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: 03/05/2019
• Supplement Date Received by Manufacturer: 05/20/2019; 10/25/2020
• Initial Report FDA Received Date: 03/31/2019
• Supplement Report FDA Received Date: 06/14/2019; 11/11/2020
• 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
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005