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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number AU00T0
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2018
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis. The product history and batch records were reviewed and documentation indicated the product met release criteria. The product investigation could not identify a root cause. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
 
Event Description
A surgeon reported that a mark was on an intraocular lens (iol) after it was inserted in a patient's eye. The mark disappeared after aspiration of the viscoelastic solution. The injector is thought to have caused the mark on the iol. The surgery was completed. There was no patient harm. This is one of two reports for this facility.
 
Manufacturer Narrative
The device was returned. The plunger is oriented correctly. Viscoelastic is observed in the device. The plunger has been retracted to mid-nozzle. No damage is observed. The nozzle was removed and cleaned for further evaluation. Top coat dye stain testing was conducted with acceptable results. There was no interior damage observed to the coating. A photo was provided for the serial number in this file. The photo is of the lens in the eye. No fold lines are observed. The area of interest is marked with a red arrow. This appears to be loose foreign material. No other determination can be made from the photograph. Product history records were reviewed and the documentation indicated the product met release criteria. The device was evaluated and no damage was observed. The nozzle was removed and cleaned for further evaluation. Top coat dye stain testing was conducted with acceptable results. There was no interior damage observed to the coating. Based on review of the provided photo the lens is not scratched and no fold lines were observed. The area of interest is marked with a red arrow. This appears to be loose foreign material. It has been indicated the material is removed with aspiration which would support the this is loose foreign material. The material was not returned for identification testing. The origin of the material cannot be determined. There no evidence the material came from the returned device. The manufacturer internal reference number is: (b)(4).
 
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Brand NameACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7274563
MDR Text Key100431453
Report Number1119421-2018-00182
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeFR
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 03/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model NumberAU00T0
Device Lot Number12525739
Other Device ID Number00380652358309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/15/2018 Patient Sequence Number: 1
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