MAUDE Adverse Event Report: JOHNSON AND 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	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided; best estimate is during (b)(6) 2018.If implanted; give date: n/a (not applicable).Unknown/not provided (b)(4).Attempts have been made to obtain additional information; however, to date a response has not been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxr00 15.5 diopter intraocular lens (iol) was explanted from the patient's operative eye on (b)(6) 2018 due to either refractive error or dysphotopsia.Reportedly, there was no patient injury.No additional information was provided.
Additional Manufacturer Narrative
Additional info: additional information was received through follow-up with the surgery center: patient's date of birth was provided and that the zxr00 intraocular lens was implanted in the left (os) eye on (b)(6) 2018 and that symptoms were first noted on this same date.Patient outcome reported as the patient is happy and symptoms have resolved.Therefore, the following fields have been updated accordingly.Age/date of birth: on (b)(6) 1949.Date of event: on (b)(6) 2018.If implanted; give date: on (b)(6) 2018.Device evaluation: the product was not returned to the manufacturing site; therefore, the complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Historical data analysis: a search of complaints revealed no similar complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product 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
Device available for evaluation: yes.Returned to manufacturer on: 3/14/2019.Device returned to manufacturer: yes.Device evaluation: the product was received dry in a little 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 issue reported was not 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 AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8251454
• Report Number: 9614546-2019-00046
• Device Sequence Number: 2125462
• Product Code: POE
• UDI-Device Identifier: 05050474591752
• UDI-Public: (01)05050474591752(17)210714
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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: 07/14/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 01/24/2019; 03/19/2019; 10/25/2020
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/11/2019; 04/09/2019; 11/06/2020
• 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: 68 YR
• Date Report Sent to FDA: 01/01/2005