I/A HANDPIECE TIP 8065750263

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 2019-12-24 for I/A HANDPIECE TIP 8065750263 manufactured by Alcon Research, Llc - Alcon Precision Device.

Event Text Entries

[177981360] 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


[177981361] A physician reported that a small fragment was detected in a patient's iris at the slit lamp review the day after a cataract procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644019-2019-00208
MDR Report Key9516768
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-12-24
Date of Report2020-03-16
Date of Event2019-12-02
Date Mfgr Received2020-03-13
Device Manufacturer Date2019-04-24
Date Added to Maude2019-12-24
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 - ALCON PRECISION DEVICE
Manufacturer Street714 COLUMBIA AVENUE
Manufacturer CitySINKING SPRING PA 19608
Manufacturer CountryUS
Manufacturer Postal Code19608
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameI/A HANDPIECE TIP
Generic NameCATHETER, IRRIGATION
Product CodeGBX
Date Received2019-12-24
Model NumberNA
Catalog Number8065750263
Lot Number293451M
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC - ALCON PRECISION DEVICE
Manufacturer Address714 COLUMBIA AVENUE SINKING SPRING PA 19608 US 19608


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-24

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