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

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.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, 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 Key: 9537045
• MDR Text Key: 173279036
• Report Number: 1119421-2019-02227
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12735675
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR