TECNIS SYMFONY TORIC UNKNOWN

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 2020-03-13 for TECNIS SYMFONY TORIC UNKNOWN manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[183371866] Date of event: unknown, not provided; best estimate is during the summer 2019. Implant date: if implanted; give date: unknown/not provided best estimate summer 2019. Explant date: if explanted; give date: n/a (not applicable). Lens remains implanted. The device was not returned as it remains implanted, therefore the product evaluation is unable to be performed. The complaint issue reported could not be verified and no product deficiency could be identified. Manufacturing records review: the manufacturing records are unable to be evaluated due to no serial number received. Historical data analysis: a search of complaints related to this production order (po) was unable to be performed due to no serial number being received. Conclusion: as a result of the investigation there is no indication of a quality product 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


[183371867] The customer account reported that a patient who had a symfony toric intraocular lens (iol) implanted in the right (od) eye and a multifocal in the left (os) eye approximately in the summer 2019. Patient is happy with the left, but has negative dysphotopsia in the right with a darkened, blurred feeling from fixation temporally. No significant surface disease and minimal capsular opacification. The lens is rotated to 35 degrees. She is 7 months post-op and has residual astigmatism: od +1-1. 5@19. 20/25 j3; os plano 20/15 j1+. The lens could be rotated to decrease the astigmatism. There is no plan for lens exchange at this time. No further information provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614546-2020-00123
MDR Report Key9827995
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-13
Date of Report2020-03-12
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-12
Date Added to Maude2020-03-13
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 Received2020-03-13
Model NumberUNKNOWN
Catalog NumberUNKNOWN
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 Received2020-03-13
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-13

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