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 Impairment (2138); No Code Available (3191)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: unknown, but the lens was planned to be explanted on (b)(6) 2018.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the zxr00 intraocular lens (iol) was implanted in the right eye (od) of a female patient on (b)(6) 2018.Reportedly, the patient complained that the vision was poor, especially at night.The uncorrected distance visual acuity in the right was not good and she did not see well in dim light; the intermediate vision was just okay.An explant was scheduled for the right eye on (b)(6) 2018.Visual acuity (va) pre-op: 20/50, j2 with correction; 20/400 glare test; 1 day post-op: uc (uncorrected) distance: 20/40-2, uc intermediate: j7; 6 day post-op: uc distance : 20/30, uc intermediate: j10; 13 day post-op: uc distance: 20/40, uc intermediate : js; 25 day post-op: uc distance: 20/40, uc intermediate: j4; 2 month post-op: uc distance: 20/60+1, uc intermediate: j2; 6 month post-op: uc distance: 20/60, uc intermediate : j3.No additional information was provided.
Additional Manufacturer Narrative
Additional information was received and it was learnt that the intraocular lens was explanted.The exact date was not provided, but the best estimate is between 10/29/2018 and 11/02/2018.Therefore (b)(4) from planned explant to explant.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.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.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 (b)(4) and capa-010215.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8036892
• Report Number: 9614546-2018-01051
• Device Sequence Number: 11121700
• Product Code: POE
• UDI-Device Identifier: 05050474579019
• UDI-Public: (01)05050474579019(17)220516
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 05/16/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0160
• 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: 10/11/2018
• Supplement Date Received by Manufacturer: 11/09/2018; 10/25/2020
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/07/2018; 11/04/2020
• 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