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
Additional information: date of event: unknown as information was not provided.The best estimate date is between (b)(6) 2019 and (b)(6) 2020.If explanted; give date: unknown as information was not provided.(b)(4).Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no similar complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.Attempts were made to contact the customer account requesting additional 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 zxr00 intraocular lens (iol) was explanted from the patient¿s ocular sinister (left eye) due to complaints of dysphotopsia.Attempts were made to contact the customer account requesting additional information however, to date no response has been received.No additional information was provided.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section d-10: device available for evaluation: yes section d-10: returned to manufacturer on: 09/21/2020 section h-3: device returned to manufacturer: yes device evaluation: the complaint lens was received at the jacksonville site, submerged in an unknown solution inside a specimen cup.The complaint lens was cleaned and visual inspection under magnification revealed no cosmetic defects.The complaint issue could not be confirmed, and no product deficiency could be identified.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue 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 nr-(b)(4) 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: 9930654
• Report Number: 9614546-2020-00173
• Device Sequence Number: 644309
• Product Code: POE
• UDI-Device Identifier: 05050474579019
• UDI-Public: (01)05050474579019(17)220713
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2020
• 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: 07/13/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 10/02/2020; 10/25/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 10/29/2020; 11/02/2020
• 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