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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate is between (b)(6) 2019 and b)(6) 2019.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted due to refractive error due to astigmatism that presented after surgery needing a toric lens to correct his vision.No wound enlargement and no vitrectomy was performed.The patient was reported doing well post-op.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Device returned to manufacturer: 3/13/2019.Device returned to manufacturer: yes.Device evaluation: visual inspection of the return sample showed that the product was cut in pieces, most probably to make the explant possible.Due to the condition of the return sample, additional analysis was not possibles.The customer''s reported complaint could not be confirmed.Manufacturing record review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.A review of 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, precautions, along with warnings for the proper use and handling of the product.As a result of the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, was 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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8403500
• Report Number: 9614546-2019-00200
• Device Sequence Number: 11260182
• Product Code: POE
• UDI-Device Identifier: 05050474579088
• UDI-Public: (01)05050474579088(17)230309
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 11/10/2020
• 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: 03/09/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 03/19/2019; 10/25/2020
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/11/2019; 11/10/2020
• 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: 81 YR
• Date Report Sent to FDA: 01/01/2005