TECNIS SYMFONY ZXR00 ZXR00U0185

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 2020-03-05 for TECNIS SYMFONY ZXR00 ZXR00U0185 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[188140516] Explant date: if explanted, give date: not applicable, lens has not been explanted. 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. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[188140517] It was reported that a patient has bilateral zxr00 intraocular lenses (iol) implanted. However, the patient is experiencing circles and glare in the form of a huge starburst at night, which has limited the patient from driving at nighttime. The symptoms are almost identical in each eyes. Both lenses are still implanted. Patient has seen his eye doctor multiple times and was using eye drops. Per the patient, nothing has worked to better his night vision. Patient states day vision is perfect but is considering a second opinion to address night vision. No further information was provided. This report captures the event for the right eye. A separate report is being submitted for the left eye.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614546-2020-00106
MDR Report Key9796297
Report SourceCONSUMER
Date Received2020-03-05
Date of Report2020-03-20
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-14
Date Added to Maude2020-03-05
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 StreetVAN SWIETENLAAN 5
Manufacturer CityGRONINGEN 9728NX
Manufacturer CountryNL
Manufacturer Postal Code9728 NX
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameTECNIS SYMFONY
Generic NameMULTIFOCAL IOLS
Product CodePOE
Date Received2020-03-05
Model NumberZXR00
Catalog NumberZXR00U0185
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 Received2020-03-05
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-05

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