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 2018-08-20 for FIBER OPTIC ILLUMINATOR 8065751577 manufactured by Alcon Research, Ltd. - Houston.

Event Text Entries

[117847353] 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


[117847354] A surgeon indicated the trocar blade was unable to prick the eye during a procedure. The procedure was completed after replacing the product. There was no harm to the patient. No additional information is expected.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644019-2018-00208
MDR Report Key7799216
Date Received2018-08-20
Date of Report2018-11-05
Date Mfgr Received2018-10-15
Device Manufacturer Date2018-04-17
Date Added to Maude2018-08-20
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. BRYAN BLAKE
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152230
Manufacturer G1ALCON RESEARCH, LTD. - 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 Received2018-08-20
Returned To Mfg2018-08-09
Model NumberNA
Catalog Number8065751577
Lot Number2145370H
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LTD. - HOUSTON
Manufacturer Address9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-20

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