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 Number2648035-2020-00221
MDR Report Key9804088
Report SourceCONSUMER
Date Received2020-03-09
Date of Report2020-03-08
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-10
Date Added to Maude2020-03-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactSOMYATA NAGPAL
Manufacturer Street1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478200
Manufacturer G1JOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer StreetROAD 402 NORTH, KM 4.2 ANASCO INDUSTRIAL PARK
Manufacturer CityANASCO PR 00610
Manufacturer CountryUS
Manufacturer Postal Code00610
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameTECNIS SYMFONY
Generic NameMULTIFOCAL IOLS
Product CodePOE
Date Received2020-03-09
Model NumberZXR00
Catalog NumberZXR00U0235
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer Address1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Device Sequence Number: 101

Product Code---
Date Received2020-03-09
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-09

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