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	Halo (2227); No Code Available (3191)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, explant was scheduled for 04/22/2019 however not yet confirmed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the iol model zxr00 20.5 diopter intraocular lens (iol) will be explanted due to the patient experiencing tremendous halos and glare.Via follow-up it was clarified that the patient was seen in the medical office with the reported symptoms on (b)(6) 2019 and again seen on (b)(6) 2019 with the symptoms not improving.An explant is scheduled for (b)(6) 2019.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.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 similar complaints have 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.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-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: 8593300
• Report Number: 9614546-2019-00438
• Device Sequence Number: 13948604
• Product Code: MFK
• UDI-Device Identifier: 05050474579101
• UDI-Public: (01)05050474579101(17)220618
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 06/18/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0205
• 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: 04/10/2019
• Supplement Date Received by Manufacturer: 06/12/2019; 10/25/2020
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 07/08/2019; 11/12/2020
• 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: 59 YR
• Date Report Sent to FDA: 01/01/2005