DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS 8065751512

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-05 for DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS 8065751512 manufactured by Alcon Research, Ltd. - Alcon Precision Device.

Event Text Entries

[57068128] 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


[57068129] A surgeon reported that the tip of the irrigation/aspiration (i/a) tip seemed rigid and felt that it was hanging on the incision. The case was completed with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


[63121074] No sample has been returned for evaluation for the report of hung on incision; therefore, the condition of the product could not be verified. No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted. A sample was not returned and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined. The manufacturer internal reference number is (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2523835-2016-00751
MDR Report Key6000065
Date Received2016-10-05
Date of Report2016-12-14
Date Mfgr Received2016-12-07
Date Added to Maude2016-10-05
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. RITA LOPEZ
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175514846
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 Report3

Device Details

Brand NameDISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS
Generic NameDEVICE, IRRIGATION, OCULAR SURGERY
Product CodeKYG
Date Received2016-10-05
Model NumberNA
Catalog Number8065751512
Lot NumberASKU
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 2016-10-05

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