MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; MONOFOCAL IOLS

Model Number ZA9003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Vertigo (2134); Visual Disturbances (2140); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, not provided.However, best estimate is (b)(6) 2019.If explanted; give date: not applicable as the lens remains implanted.The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The patient called and claims to see into the uv (ultra violet) spectrum and fears that uv rays might be damaging his eyes.Left eye was done on (b)(6) 2019.Right eye was done yesterday, (b)(6) 2019.The patient provided additional details stating he has to wear really big uv sunglasses during the day.He is seeing more of the purple/violet spectrum versus the blue spectrum when he looks at the sky.Sunsets are beautiful.A gray carpet/rug looks violet, not gray.He also gets a ''pulsing'' in his eyes.He only had the lenses put in 3 and 5 weeks ago.He developed cataracts early due to a concussion suffered a few years ago.He is a (b)(6) year-old man who is still works.Unfortunately, he is unable to work at the plant due to the fluorescent lights in his work area/bays.The entire work area is the size of a football field with fluorescent lights overhead.He is, however, able to work remote; but needs to keep the blinds shut during the day and does not use fluorescent lighting in his home office.He has been back to the surgery center to discuss is concerns and was told by the staff (including the surgeon) there is nothing else they can do for him and he needs to see his local eye doctor, which he has.His visual acuity is excellent at 20/15 (1st eye) and almost at 20/10 at the time of the call.Second eye is 20/20 and getting better.It was shared with the patient that it will still take some time for his brain and eyes to work together, called neuroadaptation.It could take 3 months or more and his doctor may have explained that too.He is not complaining as much as he wants to know the why and what he may have to do in the future.He did go online and look at the directions for use for the model za9003 lens.He stated the lens has uv protection.It was encouraged that he continues to see his eye doctor who may be able to provide glasses with uv protection to help compensate.He is going to see the local eye doctor soon as he needs reading glasses/computer glasses.He is otherwise very happy with the lenses.The patient was provided with stats on the uv effects/controls with the lenses.Further information was received and the patient has indicated that the uv factor and lighting is now affecting his work and daily life.Patient had bilateral lens implants.This report represents his right eye and another report will be filed on his left eye.

Manufacturer Narrative

The patient provided additional information.The patient now reports nausea, continued pulsing in his eyes, and flickering.He is going to his primary care doctor, a neurologist, and also back to the surgery center where he had the lens implanted.He states "i thought it might have something to do with all the new blue light i am seeing, but my best guess so far, is that it is the flickering of lights that is causing the nausea.It has a term: flicker vertigo".The following patient codes have been added as a result of the additional information received: (b)(4).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 (b)(4) and capa-010215.

• Brand Name: TECNIS
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8706080
• MDR Text Key: 148265336
• Report Number: 2648035-2019-00647
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474528987
• UDI-Public: (01)05050474528987(17)240131
• Combination Product (y/n): Y
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030185
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 06/21/2019; 10/25/2020
• Supplement Dates FDA Received: 07/18/2019; 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR