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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number SN6CWS
Device Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/16/2019
Event Type  malfunction  
Manufacturer Narrative
This report is being resubmitted. It was originally submitted on 9-oct-2019 with core id: 1570637102889. 896741@nuitjjo1i2uepfib4ku
=
and could not be processed by cdrh. Refer to cesub ticket # csh-16702. A sample product was not returned for analysis. Product and complaint history records were reviewed. The product met release criteria. A root cause was not determined. There are no other complaints in the lot. Additional information was requested. The manufacturer internal reference number is: (b)(4).
 
Event Description
A surgeon reported that during an intraocular lens implant procedure, white particles were seen with the lens. The lens remains implanted. There is no indication of patient harm. Additional information was requested.
 
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Brand NameACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
jason michaelides
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175686438
MDR Report Key9315130
MDR Text Key186147968
Report Number1119421-2019-01652
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model NumberSN6CWS
Device Catalogue NumberSN6CWS.190
Device Lot Number12347581
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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