FIBER OPTIC ILLUMINATOR 8065751577

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-11 for FIBER OPTIC ILLUMINATOR 8065751577 manufactured by Alcon Research, Llc - Houston.

Event Text Entries

[142048869] 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


[142048870] A customer reported that a trocar head part detached when the tip of the chandelier was taken out of the eye. The remained metal part (shaft) was removed without any problem and there was no effect on the patient. The surgery was completed without product replacement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644019-2019-00046
MDR Report Key8503535
Date Received2019-04-11
Date of Report2019-07-08
Date Mfgr Received2019-06-26
Device Manufacturer Date2018-08-27
Date Added to Maude2019-04-11
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 - HOUSTON
Manufacturer Street9965 BUFFALO SPEEDWAY
Manufacturer CityHOUSTON TX 77054
Manufacturer CountryUS
Manufacturer Postal Code77054
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameFIBER OPTIC ILLUMINATOR
Generic NameLIGHT, SURGICAL, FIBEROPTIC
Product CodeFST
Date Received2019-04-11
Returned To Mfg2019-04-17
Model NumberNA
Catalog Number8065751577
Lot Number2191013H
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC - HOUSTON
Manufacturer Address9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-11

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