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 2018-07-30 for EDGEPLUS VALVED ENTRY SYSTEM 8065751657 manufactured by Alcon Research, Ltd. - Irvine Technology Center.

Event Text Entries

[115649792] 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


[115649793] A facility reported that the trocars are being pulled out of the eye when removing instruments because instruments are getting stuck. Patient and procedure impact are unknown. The facility has declined consent to follow-up.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2018-01610
MDR Report Key7733009
Date Received2018-07-30
Date of Report2018-08-15
Date Mfgr Received2018-08-03
Date Added to Maude2018-07-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 Received2018-07-30
Model NumberNA
Catalog Number8065751657
Lot NumberASKU
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 2018-07-30

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