ACRYSOF IQ RESTOR SINGLEPIECE IOL SV25T0 SV25T0U220

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-08 for ACRYSOF IQ RESTOR SINGLEPIECE IOL SV25T0 SV25T0U220 manufactured by Alcon Research, Llc - Huntington.

Event Text Entries

[182510602] A sample device was not returned for analysis. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. There have been no other complaints reported in the lot number. Additional information has been requested. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[182510603] A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced visual disturbances. The iol was exchanged for another lens two months following the initial implant procedure. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1119421-2020-00399
MDR Report Key9804026
Report SourceOTHER
Date Received2020-03-08
Date of Report2020-03-08
Date Mfgr Received2020-02-12
Device Manufacturer Date2016-12-14
Date Added to Maude2020-03-08
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 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 RESTOR SINGLEPIECE IOL
Generic NameLENS, MULTIFOCAL INTRAOCULAR
Product CodeMFK
Date Received2020-03-08
Model NumberSV25T0
Catalog NumberSV25T0U220
Lot Number12511907
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 2020-03-08

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