MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D 8065977763

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 2020-02-17 for MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D 8065977763 manufactured by Alcon Research, Llc - Huntington.

Event Text Entries

[183488096] Evaluation summary: investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[183488097] A customer reported there were three instances of intraocular lenses (iols) appearing to have a hole, chip, or tear in them. The customer is confident it is being caused by the cartridge as the cartridges appear to be 'irregular' on the inside. There is no reported patient impact. Additional information was requested. There are three reports associated with this as two lot numbers were provided and one is unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1119421-2020-00243
MDR Report Key9716522
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-17
Date of Report2020-02-17
Date of Event2020-01-23
Date Mfgr Received2020-01-27
Device Manufacturer Date2019-09-05
Date Added to Maude2020-02-17
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 NameMONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
Generic NameFOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
Product CodeMSS
Date Received2020-02-17
Model NumberNA
Catalog Number8065977763
Lot Number32740263
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 2020-02-17

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