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	Blurred Vision (2137); Halo (2227); No Code Available (3191)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date: not applicable; to date the lens remains implanted.Device evaluation: product evaluation was not performed because the lens is still implanted in the patent's eye.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order number.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 the patient complained of halos and glare following the implant of a symfony intraocular lens (iol).The patient opted not to have an iol exchange as the patient thought he could live with the symptoms.A lasik procedure was performed, however, afterwards the patient is not sure if he can live with the symptoms.Additional information reported the patient also complained of blurred vision.The physician's opinion is there is nothing wrong with the iol.No additional information was received.
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:(b)(4).

• 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: 9663187
• Report Number: 2648035-2020-00108
• Device Sequence Number: 2883863
• Product Code: POE
• UDI-Device Identifier: 05050474579033
• UDI-Public: (01)05050474579033(17)231208
• Combination Product (Y/N): Y
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020
• 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: 12/08/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0170
• 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: 01/08/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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: 69 YR
• Date Report Sent to FDA: 01/01/2005