EDGEPLUS VALVED ENTRY SYSTEM 8065751657

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-14 for EDGEPLUS VALVED ENTRY SYSTEM 8065751657 manufactured by Alcon Research, Ltd. - Irvine Technology Center.

Event Text Entries

[95068709] 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


[95068710] A customer reported that "a couple of cannulas have been reported to bubble up nothing flowing" during surgery. No patient harm reported. Additional information was requested; however, none has been received to date.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2017-04520
MDR Report Key7118345
Date Received2017-12-14
Date of Report2018-02-15
Date Mfgr Received2018-02-09
Device Manufacturer Date2017-09-18
Date Added to Maude2017-12-14
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 Received2017-12-14
Model NumberNA
Catalog Number8065751657
Lot Number17031514X
ID NumberNA
Device Expiration Date2019-08-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
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 2017-12-14

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