ACRYSOF IQ PANOPTIX TRIFOCAL IOL TFNT00 TFNT00U245

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for ACRYSOF IQ PANOPTIX TRIFOCAL IOL TFNT00 TFNT00U245 manufactured by Alcon Research, Llc - Huntington.

Event Text Entries

[185894181] The product was not returned. Product history records were reviewed and the documentation indicated the product met release criteria. The product investigation could not identify a root cause. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[185894182] A surgical manager reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision and diplopia. The iol was exchanged for another lens seven weeks following the initial implant procedure. Failed refractive symptom treatment for blurry vision and diplopia was the clinical reason given for the explant. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1119421-2020-00573
MDR Report Key9908148
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-06
Device Manufacturer Date2019-09-20
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JONATHAN SCHLECH
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175514979
Manufacturer G1ALCON RESEARCH, LLC - HUNTINGTON
Manufacturer Street6065 KYLE LANE
Manufacturer CityHUNTINGTON WV 25702
Manufacturer CountryUS
Manufacturer Postal Code25702
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameACRYSOF IQ PANOPTIX TRIFOCAL IOL
Generic NameLENS, MULTIFOCAL
Product CodeMFK
Date Received2020-03-31
Model NumberTFNT00
Catalog NumberTFNT00U245
Lot Number12743601
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC - HUNTINGTON
Manufacturer Address6065 KYLE LANE HUNTINGTON WV 25702 US 25702


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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