EDGEPLUS VALVED ENTRY SYSTEM 8065751658

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-23 for EDGEPLUS VALVED ENTRY SYSTEM 8065751658 manufactured by Alcon Research, Ltd. - Irvine Technology Center.

Event Text Entries

[93213457] 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


[93213458] A customer reported to a company representative the valved trocar detached from the sclera during removal of the laser probe during an unknown number of vitreo-retinal procedures. Forceps were required to removed the valved trocar from the laser probes. There was no harm to the patients and the samples were not retained. Additional information was requested; however, none has been received to date. This is one of two reports.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2017-04366
MDR Report Key7056717
Date Received2017-11-23
Date of Report2018-02-26
Date of Event2017-11-01
Date Mfgr Received2018-02-19
Date Added to Maude2017-11-23
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 ContactMS. NADIA BAILEY
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152230
Manufacturer G1ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
Manufacturer Street15800 ALTON PARKWAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameEDGEPLUS VALVED ENTRY SYSTEM
Generic NameCANNULA, TROCAR, OPHTHALMIC
Product CodeNGY
Date Received2017-11-23
Returned To Mfg2018-02-13
Model NumberNA
Catalog Number8065751658
Lot NumberASKU
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
Manufacturer Address15800 ALTON PARKWAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-11-23

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