TECNIS SYMFONY ZXR00 ZXR00U0230

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for TECNIS SYMFONY ZXR00 ZXR00U0230 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[188486131] Date of event: unknown, not provided, but the best estimate is between 8/15/2018 and 10/31/19. (b)(4). Device evaluation: product testing could not be performed because the product was discarded. The reported complaint was not confirmed. Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported. The search revealed that no other complaints have been received for this production order number. Conclusion: as a result of the investigation, there is no indication of a product quality deficiency. All pertinent information available to johnson and johnson surgical vision has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[188486132] It was reported that tecnis symfony multifocal intraocular lens (model zxr00 +23. 0 diopter) was explanted from patient? S left (os) eye because of patient experiencing blurry/waxy vision. Reportedly a lens from another manufacturer with same diopter was used as replacement for the patient. Incision enlargement was performed and sutures were required during the procedure. Visual acuity pre-op was 20/20. The device has been discarded. No further information provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614546-2020-00120
MDR Report Key9824239
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-12
Date of Report2020-03-12
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-18
Date Added to Maude2020-03-12
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 Received2020-03-12
Model NumberZXR00
Catalog NumberZXR00U0230
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 Received2020-03-12
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-12

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