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 from a health professional report with the FDA on 2017-09-18 for DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS 8065751512 manufactured by Alcon Research, Ltd. - Alcon Precision Device.

Event Text Entries

[86555256] 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


[86555257] A surgeon reported that he feels that the irrigation/aspiration tip is stripping the descemet from the corneal surface when entering the incision during surgery. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


[112060256] No disposable polymer i/a product was returned for evaluation for the report of the tip stripping the descemet from the corneal surface; therefore, the condition of the product could not be verified. No lot number was identified with this complaint; therefore, a lot history review could not be conducted. Because a sample was not returned and no lot information was provided for a lot record review, the root cause for customer complaint issue cannot be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2523835-2017-00708
MDR Report Key6873628
Report SourceHEALTH PROFESSIONAL
Date Received2017-09-18
Date of Report2017-11-01
Date of Event2017-08-24
Date Mfgr Received2017-10-24
Date Added to Maude2017-09-18
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. NADIA BAILEY
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 Report3

Device Details

Brand NameDISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS
Generic NameDEVICE, IRRIGATION, OCULAR SURGERY
Product CodeKYG
Date Received2017-09-18
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 2017-09-18

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