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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number AU00T0
Device Problem Unintended Movement (3026)
Patient Problems Vitreous Floaters (1866); Blurred Vision (2137); Visual Disturbances (2140)
Event Type  Injury  
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. (b)(4).
 
Event Description
A consumer reported that it looks like a disco ball in his eye/flashes of lights two weeks after an intraocular lens (iol) implantation procedure. Additional information was provided by the consumer, who reported that he has seen his ophthalmologist and retina specialists several times since the surgery. It is still the same with no improvements. The doctors do not understand. The lens is moving, causing a flickering, shimmering fluttering affect, like there is a disco party going on inside the eye. It is mainly seen from my peripheral temple side. The consumer can not drive or work. When in a low lit room or if the eye is dilated, it become almost non-existent. His ophthalmologist thinks it may stop after a month. He said if it is still doing it, he was going to remove the iol. Further details were provided by the consumer, who reported that he sees the lens moving, wobbling back and forth. He see the light reflection from the light moving, like a disco ball or like a flash on the peripheral vision. If the eye is stationary he does not see it. If he is at a store with florescent or led lights he notices it all the time. He also has a pulling feeling, like he can't move the eyes correctly. If he puts his reading glasses on it corrects it. If he puts the uv light glasses on that helps with the eyes a little. When he dilated he sees the haptics clearly. He cannot work or drive. When he looks down it is worse and the flickering is slower. When he stands up it is faster. He has seen his doctor seven times and was given dilation drops. The symptoms improve with the drops and it almost goes away. He is experiencing blurred vision. It was clear after surgery, then it slowly deteriorated and is almost worse than the cataract. Shrinking pupil drops clear this up; however, he has not used them in a week because the flickering gets bad, images are moving or jumping around. He used these drops twice and then he did not take them anymore. When he is watching tv, everything seems normal but as soon as he gets near lights it all begins. The consumer saw a doctor last week and was told that his lens looks ok. He reported that he sees a halfmoon shape in his vision. The images are distorted at the end of the lens, temporal right. He is going to a retina specialist for a giant floater, that comes and goes and it started on thursday. He does not know if it lens related or the eye.
 
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Brand NameACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT 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 Key9537045
MDR Text Key173279036
Report Number1119421-2019-02227
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2022
Device Model NumberAU00T0
Device Lot Number12735675
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/20/2019
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: 12/31/2019 Patient Sequence Number: 1
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