CONSTELLATION SURGICAL PROCEDURE PAK 8065752439

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 2020-03-23 for CONSTELLATION SURGICAL PROCEDURE PAK 8065752439 manufactured by Alcon Research, Llc - Houston.

Event Text Entries

[184478524] 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


[184478525] A healthcare professional reported an iop compensation issue with the system during a vitrectomy procedure. There was a decrease of the pressure. In response, the surgeon increased the intraocular pressure and decreased aspiration. The procedure was completed. The patient experienced a choroidal detachment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644019-2020-00165
MDR Report Key9865825
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-02-25
Date Mfgr Received2020-02-25
Device Manufacturer Date2019-09-05
Date Added to Maude2020-03-23
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 SURGICAL PROCEDURE PAK
Generic NameGENERAL SURGERY TRAY (KIT)
Product CodeLRO
Date Received2020-03-23
Model NumberNA
Catalog Number8065752439
Lot Number2311821H
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC - HOUSTON
Manufacturer Address9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-23

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