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

Model Number ZXT150

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2018 and (b)(6) 2018.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a zxt150 24.0 diopter intraocular lens was implanted in the patient's left eye on (b)(6) 2018.It was later explanted on (b)(6) 2018 due to a myopic surprise and the patient being unhappy with the lens.There was no incision enlargement, no vitrectomy, and no sutures used.The replacement lens was the same model, but different diopter of 22.0.Reportedly, there was no patient injury and the patient is doing fine post-operatively.No additional information was provided.

Manufacturer Narrative

Device available for evaluation; returned to manufacturer on: 02/20/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection using microscope magnification was performed: the returned zxt150 sample was received with the lens cut.The condition observed is consistent with a lens that has been explanted.The complaint issue reported as myopic was not confirmed and due the condition of the zxt150 lens received the complaint could not be related to the manufacturing process; therefore, a product quality deficiency was not identified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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 & johnson surgical vision, inc.Has been submitted.

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-0148919 and capa-010215.

• Brand Name: TECNIS SYMFONY TORIC
• Type of Device: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8346858
• MDR Text Key: 136468117
• Report Number: 2648035-2019-00201
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 05050474605282
• UDI-Public: (01)05050474605282(17)230810
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention