MAUDE Adverse Event Report: JOHNSON AND 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	Irritation (1941); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, but the best estimate is between 4/12/2018 and 07/04/2018.If explanted, give date: not applicable as to date the lens remains implanted and therefore not explanted.(b)(4).Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site as to date it remains implanted; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported a bilateral intraocular lens (iol) implant.Right eye: zxt150 +21.0 diopter implanted on (b)(6) 2018; left eye: zxt150 +21.0 diopter implanted on (b)(6) 2018.Reportedly, the patient is unhappy.She cannot drive at night as it is too dangerous.She can see giant sunbursts surrounding halos around lights, shadows on the side of the right eye.The left eye has waves on left side like ''heat waves''.The eyes always feel irritated and raw.The patient commented that her side vision is impaired.Additional information was received and it was learnt that the surgeon advised the patient to give her eyes time to adapt.Her eyes are still irritated and she has not sought treatment for this issue yet.The patient also mentioned that she does not want to have any additional procedures performed.No further information was provided.This mdr is to record the lens implanted in the right eye.A separate report will be submitted for the 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 AND JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7823109
• Report Number: 9614546-2018-00824
• Device Sequence Number: 16429845
• Product Code: POE
• UDI-Device Identifier: 05050474605220
• UDI-Public: (01)05050474605220(17)211201
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 12/01/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U210
• 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: 08/02/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 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: Other
• Date Report Sent to FDA: 01/01/2005