MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION TECNIS SYMFONY TORIC; MULTIFOCAL IOLS

Model Number	ZXT225
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	08/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the multifocal zxt225 19.5 diopter intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye) on (b)(6) 2017.The lens was explanted on (b)(6) 2018 due to the patient being unable to tolerate halos, glare, and spoking.A monofocal lens (model and diopter unknown) was implanted as a replacement.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens was not returned; therefore, a product investigation could not be performed and the customer's reported event could not be confirmed.Manufacturing records review: a review of the manufacturing records was performed.The product was manufactured according to specification.A search revealed that no similar complaints were received for this production order number.Labeling review: directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, along with warnings for the proper use and handling of the product.Based on the results of the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Was submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in 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- (b)(4).

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8157981
• Report Number: 9614546-2018-01163
• Device Sequence Number: 295364
• Product Code: POE
• UDI-Device Identifier: 05050474605787
• UDI-Public: (01)05050474605787(17)220522
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 05/22/2022
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 12/21/2018; 10/25/2020
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 12/21/2018; 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: 76 YR
• Date Report Sent to FDA: 01/01/2005