TECNIS SYMFONY ZXR00 ZXR00U0235

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-09 for TECNIS SYMFONY ZXR00 ZXR00U0235 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[183683043] Date of event: unknown, not provided, but the best estimate date is during 2019. If explanted, give date: not applicable, remains implanted in the eye. 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, 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 and johnson surgical vision has been submitted.
Patient Sequence No: 1, Text Type: N, H10

[183683044] It was reported that patient was experiencing halos post intraocular lens (iol) implants in (b)(6) 2019 in both eyes. Reportedly the cataract was performed 1-2 years after having lasik to remove bump on her eye, to smooth the cornea. Surgeon had to have fluid drained from both her eyes about 6 weeks ago. Surgeon states that patient now has dry eye, requiring lipiflow treatments. Plugs were put in her tear ducts to keep fluid in her eyes instead of flowing out. Surgeon prescribed her glasses for glare, but she still can? T see when watching tv patient stated that she had an incident where she thought she needed to go to the emergency room but could not drive herself because it was too hard to see between light and dark with the giant halos around light sources. She is wanting to see if the dry eye is causing a problem with the lens. Her surgeon is saying this is the case. Additional information was received and it was learnt that she is not able to drive at night, tv glows badly, has lot of issue with led light. Doctor did provide her complimentary anti-glare glasses which helped her for some time. However, she is still having a lot of glare at night. Doctor did talk about option of lens exchange however he thinks that that can affect depth of vision. This event will capture information for her right eye. A separate report is being submitted for patient? S left eye. No further information provided.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2648035-2020-00221
• MDR Report Key: 9804088
• Report Source: CONSUMER
• Date Received: 2020-03-09
• Date of Report: 2020-03-08
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-10
• Date Added to Maude: 2020-03-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: SOMYATA NAGPAL
• Manufacturer Street: 1700 EAST ST. ANDREW PLACE
• Manufacturer City: SANTA ANA CA 92705
• Manufacturer Country: US
• Manufacturer Postal: 92705
• Manufacturer Phone: 7142478200
• Manufacturer G1: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Street: ROAD 402 NORTH, KM 4.2 ANASCO INDUSTRIAL PARK
• Manufacturer City: ANASCO PR 00610
• Manufacturer Country: US
• Manufacturer Postal Code: 00610
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: TECNIS SYMFONY
• Generic Name: MULTIFOCAL IOLS
• Product Code: POE
• Date Received: 2020-03-09
• Model Number: ZXR00
• Catalog Number: ZXR00U0235
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Address: 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-09
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-09