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 Code	Halo (2227)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/not provided.If explanted; give date: n/a (not applicable).The lens remains implanted.Device evaluation: the device was not returned at the manufacturing site as the lens remains implanted; 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.A search of complaints revealed one other complaint was received under this production order; however, it was a low level risk and no investigation was required.The complaint was not confirmed.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
It was reported that the patient began seeing halos when she drives at night post implantation of an intraocular lens (iol) in her right eye last year.The patient was implanted with an iol in the left eye prior to the implant in the right eye.The patient sees perfectly and is very happy with her vision, except for night driving.The patient stated the halos are so big she cannot see the road.The halos only appear with car headlights.The patient can drive on the freeway; however, she cannot drive on regular streets.The patient has tried to use yellow lens glasses and sunglasses, but neither have helped with the halos.Through follow-up, the patient reaffirmed she sees halos while driving on city streets and while looking at red lights.The patient noticed the halos about a month after she had her second eye (right eye) done on (b)(6) 2019.The patient indicated that she did not drive for a while and only noticed the halos when she started driving at night.The patient had her 1-year visit and the surgeon stated everything looked fine and her eye pressure is great.No other information was provided.Patient had bilateral lens implants.This report captures the lens implanted in patients left eye.
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 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: 9936387
• Report Number: 9614546-2020-00177
• Device Sequence Number: 16768449
• Product Code: POE
• UDI-Device Identifier: 05050474605244
• UDI-Public: (01)05050474605244(17)221121
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020
• 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: 11/21/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U220
• 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: 03/11/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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