TECNIS SYMFONY TORIC ZXT300 ZXT300U180

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2020-03-25 for TECNIS SYMFONY TORIC ZXT300 ZXT300U180 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[188490541] If explanted, give date: not applicable, as lens remains implanted. (b)(4). Device evaluation: product testing could not be performed because the product was not returned as lens remains implanted. The complaint cannot be confirmed. 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. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[188490542] It was reported that clinical study patient underwent bilateral intraocular lens (iol) implants. At 1 month visit however, it was reported that the patient was very bothered by halos, very distractive in buildings; extremely bothered by starbursts, had safety concerns with driving; extremely bothered by multiple or double vision, totally disabling when it occurs; very bothered by glare, driving; moderately bothered by poor low light vision, nuisance. Preoperative visual acuity: best corrected distance visual acuity (bcva), right eye (od) 20/20; left eye (os) 20/20 the monocular uncorrected distance visual acuity (ucdva)? Od 20/25; os 20/25. Monocular bcdva? Od 20/15; os 20/15. On ocular exam posterior capsule opacification (pco)- both eyes, was noted. The subject is scheduled to have a yttrium aluminum garnet (yag) capsulotomy for the posterior capsule opacification (pco- laser treatment) in 1 week for the od and 3 weeks for the os. It was learnt that the subject had yag of od on (b)(6) 2020. Then on (b)(6) 2020 another yag for the os. The patient visual acuity is unknown at this time. No other intervention is planned. No further information available. 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 Number9614546-2020-00149
MDR Report Key9881582
Report SourceHEALTH PROFESSIONAL,STUDY,USE
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-01-07
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-25
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 Received2020-03-25
Model NumberZXT300
Catalog NumberZXT300U180
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 Received2020-03-25
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.