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); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: an exact date was not provided but the account commented that the onset of symptoms was (b)(6) 2018.(b)(4).All pertinent information available to johnson and johnson vision has been submitted.
Event or Problem Description
It was reported that the tecnis symfony multifocal intraocular lens (model zxr00, +13.5 diopter) was explanted from the patient¿s right eye because of patient experiencing bothersome glare when driving at night.A competitor lens was used as a replacement.No incision enlargement, no vitrectomy was performed, no sutures were used and no patient injury occurred.Reportedly, a posterior capsule yag (yttrium aluminum garnet) was performed.The patient¿s vision was reported as improved.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 10/02/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye shows the product is damaged, most probably to make explant possible.The product was also inspected using a microscope with a 12x magnification.It can be seen that the lens is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.Also the product is being cut in.Investigation of the return sample and the condition of the return sample do not suggest the damage was introduced during manufacturing.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were 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.; santa ana CA
• MDR Report Key: 7905282
• Report Number: 9614546-2018-00908
• Device Sequence Number: 19217248
• Product Code: POE
• UDI-Device Identifier: 05050474591714
• UDI-Public: (01)05050474591714(17)220124
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020
• 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: 01/24/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 11/01/2018; 10/25/2020
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/09/2018; 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
• Date Report Sent to FDA: 01/01/2005