CONSTELLATION ULTRAVIT PROBE 8065751438

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-01-06 for CONSTELLATION ULTRAVIT PROBE 8065751438 manufactured by Alcon Research, Llc - Houston.

Event Text Entries

[179800683] 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. A product sample has been shipped; however, it has not been received for evaluation at the manufacturing site. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[179800684] A customer reported that the probe cutter did not working during a procedure. The product was replaced and procedure completed with no patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644019-2020-00018
MDR Report Key9553261
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-01-06
Date of Report2020-04-03
Date of Event2019-12-16
Date Mfgr Received2020-03-17
Device Manufacturer Date2019-04-29
Date Added to Maude2020-01-06
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 - 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 Report3

Device Details

Brand NameCONSTELLATION ULTRAVIT PROBE
Generic NameVITRECTOMY, INSTRUMENT CUTTER
Product CodeMLZ
Date Received2020-01-06
Returned To Mfg2020-02-12
Model NumberNA
Catalog Number8065751438
Lot Number2270765H
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 2020-01-06

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