ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC 8065149530

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-29 for ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC 8065149530 manufactured by Alcon Research, Llc - Alcon Precision Device.

Event Text Entries

[125604351] No sample has been received by manufacturing for evaluation. 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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[125604352] A pharmacist reported that a 25g soft tip cannula was not compatible with a trocar prior to the start of cataract and vitrectomy surgery. There was no patient involvement and therefore no patient impact associated with this reported event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523835-2018-00443
MDR Report Key8016563
Date Received2018-10-29
Date of Report2018-10-29
Date of Event2018-10-17
Date Mfgr Received2018-10-18
Device Manufacturer Date2018-02-08
Date Added to Maude2018-10-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
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. - ALCON PRECISION DEVICE
Manufacturer Street714 COLUMBIA AVENUE
Manufacturer CitySINKING SPRING PA 19608
Manufacturer CountryUS
Manufacturer Postal Code19608
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
Generic NameCANNULA, OPHTHALMIC
Product CodeHMX
Date Received2018-10-29
Returned To Mfg2019-04-26
Model NumberNA
Catalog Number8065149530
Lot Number234345M
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC - ALCON PRECISION DEVICE
Manufacturer Address714 COLUMBIA AVENUE SINKING SPRING PA 19608 US 19608


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-29

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