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 Code	No Code Available (3191)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 other 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.
Event or Problem Description
It was reported that a zxr00 11.5 diopter lens will be explanted from the patients right eye due to refractive miss of -2 and -2.5, the difference is between auto fraction and manifest.The variance remains each time the doctor checks.Per the customer, it's possibly due to the multifocal nature of the iol.The explant was scheduled for (b)(6) 2019, and was confirmed that the explant did occur as planned.There was no patient injury reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on, 07/30/2019.Device returned to manufacturer: yes.Device evaluation: the product was received dry in a jar.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The complaint cannot be confirmed.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: 8725291
• Report Number: 9614546-2019-00574
• Device Sequence Number: 13885575
• Product Code: POE
• UDI-Device Identifier: 05050474591677
• UDI-Public: (01)05050474591677(17)220127
• 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
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 01/27/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 08/07/2019; 10/25/2020
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 08/09/2019; 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: 58 YR
• Date Report Sent to FDA: 01/01/2005