DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS 8065751511

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-26 for DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS 8065751511 manufactured by Alcon Research, Ltd. - Alcon Precision Device.

Event Text Entries

[101155266] 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


[101155268] A customer reported a sharp burr on the end of the disposable ia (irrigation/aspiration) tip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523835-2018-00087
MDR Report Key7297760
Date Received2018-02-26
Date of Report2018-05-03
Date Mfgr Received2018-04-22
Date Added to Maude2018-02-26
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. - 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 NameDISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS
Generic NameDEVICE, IRRIGATION, OCULAR SURGERY
Product CodeKYG
Date Received2018-02-26
Model NumberNA
Catalog Number8065751511
Lot NumberASKU
ID Number380657515110
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
Manufacturer Address714 COLUMBIA AVENUE SINKING SPRING PA 19608 US 19608


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-02-26

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