EDGEPLUS VALVED ENTRY SYSTEM 8065750882

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-14 for EDGEPLUS VALVED ENTRY SYSTEM 8065750882 manufactured by Alcon Research, Ltd. - Irvine Technology Center.

Event Text Entries

[100276857] 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


[100276858] An ophthalmologist reported leaking trocars during multiple surgeries. The number of patients and devices involved are unknown. The procedures were completed without changing out the product. The procedures were completed without patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2018-00300
MDR Report Key7271600
Date Received2018-02-14
Date of Report2018-05-02
Date of Event2018-01-25
Date Mfgr Received2018-04-25
Date Added to Maude2018-02-14
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 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. - 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 Received2018-02-14
Model NumberNA
Catalog Number8065750882
Lot NumberASKU
ID NumberNA
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 2018-02-14

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