TECNIS SYMFONY ZXR00 ZXR00I0235

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-04 for TECNIS SYMFONY ZXR00 ZXR00I0235 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[186752655] (b)(4). If implanted; give date: unknown/not provided. If explanted; give date: not applicable as the iol remains implanted in the patient's operative eye. Initial reporter phone number: (b)(6). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[186752656] It was reported that during post-operative examination, a patient reported of experiencing high amount of halos and glares with the intraocular lenses, model zxr00. Reportedly, the patient is also observing (ring) in periphery of right eye (od). The post-op visual acuity was reported to be ok. It was noted that the device is not available for investigation. There were no surgical interventions required and as of now doctor is not planning to perform an explant. Visual acuity pre-operative: 6/36, n/24, visual acuity post-operative: 6/9, n/8 r[s-0. 50, c-0. 50] l[s-0. 50, c-0. 50]. No additional information was provided. The patient had bilateral lens implant and this report pertains to the patient's right eye (od). A separate report is being submitted for the patient's left eye (os).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614546-2020-00093
MDR Report Key9783981
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-04
Date of Report2020-03-31
Date of Event2019-05-22
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
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 Received2020-03-04
Model NumberZXR00
Catalog NumberZXR00I0235
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 Received2020-03-04
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-04

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