MONARCH IOL DELIVERY SYSTEM, CARTRIDGE ASKU

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-26 for MONARCH IOL DELIVERY SYSTEM, CARTRIDGE ASKU manufactured by Alcon Research, Llc - Huntington.

Event Text Entries

[184445441] Evaluation summary: cartridge complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation. Root cause has not been identified. Additional information was requested. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[184445442] A customer reported upon implanting an intraocular lens (iol) a foreign substance that appeared to be a piece of plastic vinyl was found on the lens optic. The material was removed and there is no reported patient impact. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1119421-2020-00314
MDR Report Key9758493
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-26
Date of Report2020-02-26
Date of Event2020-02-06
Date Mfgr Received2020-02-06
Date Added to Maude2020-02-26
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 NameMONARCH IOL DELIVERY SYSTEM, CARTRIDGE
Generic NameFOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
Product CodeMSS
Date Received2020-02-26
Model NumberASKU
Catalog NumberASKU
Lot NumberASKU
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
10 2020-02-26

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