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
Explant date: if explanted, give date: unknown, information not provided.However, the lens is planned to be explanted on (b)(6) 2018.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxt150 21.5 diopter lens was implanted in the patient's operative eye.However, the lens is planned to be explanted on (b)(6) 2018 for unknown reasons.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing was not performed as the complaint device was not returned for evaluation.The reported complaint cannot be verified.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specifications.A complaint history search revealed no similar complaints were received for this production order number to date.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
If implanted, give date: (b)(6) 2017.If explanted, give date: (b)(6) 2018.Patient code (b)(4).Per follow-up information, patient complained of "spider web" effect on his left eye (os) around lights along with halos and was unable to drive at night.For these reasons, iol had to be removed.Per account, the patient was first examined on (b)(6) 2017.It was noted that patient had no contributing medical history, no patient injury and no secondary surgical intervention required.Lens will not be returned.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7449651
• Report Number: 9614546-2018-00365
• Device Sequence Number: 16430148
• Product Code: POE
• UDI-Device Identifier: 05050474605237
• UDI-Public: (01)05050474605237(17)220519
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/27/2018

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: Physician
• Device Expiration Date: 05/19/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/07/2018; 06/26/2018
• Initial Report FDA Received Date: 04/21/2018
• Supplement Report FDA Received Date: 06/05/2018; 06/27/2018
• 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