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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.If explanted; give date: n/a (not applicable).The lens remains implanted.Device evaluation: the device was not returned at the manufacturing site; therefore; product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The patient reported having bilateral implants in (b)(6) 2017 and is seeing halos and starburst around the lights.The patient also see's shadow lines which her doctor informed her that she is seeing the ridges on the lens.The patient has been seeing her doctor every six months and was told there is nothing the doctor can do.At this time, the lens remains implanted.No additional information was provided.This report represent the lens implanted in patients right eye.
Additional Manufacturer Narrative
Further information was provided and the patient reported seeing glare and has sensitivity to light.The patient continues to see shadow's and her surgeon stated it could be floaters.The patient indicated that her vision is good and does not need to wear glasses, however, she has stopped driving at night as the symptoms have hindered her lifestyle.The patient has had lasik performed twice; once right after the surgery and another lasik performed approximately 6 months after her iol implants.No additional information was provided.The following section has been updated accordingly: patient code: 3191 - sensitivity to light, patient code: 3191 - glare.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 TORIC
• 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: 8790794
• Report Number: 9614546-2019-00614
• Device Sequence Number: 1822772
• Product Code: POE
• UDI-Device Identifier: 05050474605183
• UDI-Public: (01)05050474605183(17)220524
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• 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: 05/24/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U190
• 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: 06/15/2019
• Supplement Date Received by Manufacturer: 08/20/2019; 10/25/2020
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 09/16/2019; 11/13/2020
• 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: Other
• Date Report Sent to FDA: 01/01/2005