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 Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: lens has not been explanted.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned; it remains implanted at this time.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.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.
Event or Problem Description
It was reported that a zxr00 19.0 diopter lens was implanted in the study patient¿s right eye (od).The patient reported experiencing severe halos and starbursts.The ucdva (uncorrected distance visual acuity) for od was 20/60.The doctor has scheduled an explant for this patient.There were no patient complications and/or related injuries.And the procedure was completed successfully.The patient's outcome did not significantly interfere with activities of daily life.No further information was 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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9301610
• Report Number: 9614546-2019-01038
• Device Sequence Number: 11253348
• Product Code: POE
• UDI-Device Identifier: 05050474579071
• UDI-Public: (01)05050474579071(17)220912
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020
• 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: 09/12/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0190
• 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: 10/16/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 11/06/2020
• 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: 74 YR
• Date Report Sent to FDA: 01/01/2005