ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC 8065440220

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC 8065440220 manufactured by Alcon Research, Llc - Alcon Precision Device.

Event Text Entries

[142194082] 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[142194083] A physician has noted there were small metal particles noted in an unknown number of patient's eyes following surgery over the last year. These particle could not be removed. Additional information has been requested. This is one of seven reports from this facility. Upon further review of provided information it was noted the surgeon used this cannula to insert dilating drops, other viscoelastic and saline solution.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612169-2019-00049
MDR Report Key8509752
Date Received2019-04-12
Date of Report2019-05-14
Date of Event2018-05-01
Date Mfgr Received2019-05-02
Date Added to Maude2019-04-12
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 ContactMS. CINDY MILAM
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152231
Manufacturer G1ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
Manufacturer Street714 COLUMBIA AVENUE MODEL FARM ROAD
Manufacturer CitySINKING SPRING PA 19608
Manufacturer CountryUS
Manufacturer Postal Code19608
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
Generic NameCANNULA, OPHTHALMIC
Product CodeHMX
Date Received2019-04-12
Model NumberNA
Catalog Number8065440220
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC - ALCON PRECISION DEVICE
Manufacturer Address714 COLUMBIA AVENUE MODEL FARM ROAD SINKING SPRING PA 19608 US 19608


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-12

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