TECNIS SYMFONY TORIC ZXT150 ZXT150U150

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 2020-03-03 for TECNIS SYMFONY TORIC ZXT150 ZXT150U150 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[186751929] Date of event: unknown, not provided. Best estimate of date of event is between 4/24/2019 and 2/3/2020. (b)(4). Device evaluation: product evaluation was not performed because per the initial report the lens is still implanted in the patient's eye. The complaint issue reported could not be verified and no product deficiency could be identified. Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications. A search revealed that no similar complaints were received from this production order. Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified. Attempts have been made to obtain missing information; however, no definitive response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[186751930] It was reported that a male patient was implanted bilateral intraocular lenses for cataract. For the left eye (os), zxr00 was implanted. Then for the right eye (od), zxt150 was implanted. Soon after both implants, the patient developed visual issues. His concerns are that his eyes are tired and repeatedly attempt to close after 5 pm. Also, his eyes feel dry, also a late afternoon observation. Both eyes tear frequently, more at evening but throughout the day. The sensation of looking through frames, as if using binoculars. His reading vision is worse than it has ever been. He had anticipated not wearing glasses. The dark spots continue to show up occasionally, but they are reduced in frequency. It was learned through follow-up that he had yttrium-aluminum-garnet laser treatment (yag) to remove cell growth. The patient mentioned that he has dry eyes and it makes his eyes feel like they have sand in them and his eyes tear. Over the counter eye drops were provided by the doctor for the dry eye symptoms. The drops have helped but have not eliminated the symptoms. His doctor had no plan to explant and provided him a letter indicating that his results fall within the parameters of a successful procedure. The patient stated that the symptoms do not significantly affect his ability to perform daily activities. No other information was provided. This mdr report pertains to the right eye (od). A separate report will be submitted for the left eye (os).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614546-2020-00092
MDR Report Key9781994
Report SourceCONSUMER
Date Received2020-03-03
Date of Report2020-03-03
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-03
Date Added to Maude2020-03-03
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 TORIC
Generic NameMULTIFOCAL IOLS
Product CodePOE
Date Received2020-03-03
Model NumberZXT150
Catalog NumberZXT150U150
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 Received2020-03-03
Device Sequence No101
Device Event Key0


Patients

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

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