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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number ACU0T0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Visual Disturbances (2140)
Event Date 01/14/2022
Event Type  Injury  
Manufacturer Narrative
A sample device was not returned for analysis. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified.   there have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
 
Event Description
A non healthcare professional reported that following implantation of an intraocular lens (iol) the patient felt like a shadow following her and the lens was explanted in a secondary procedure with non company lens. Additional information was received stating the patient was not hospitalized for the event and there was no patient harm.
 
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Brand NameACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH 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
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key13582928
MDR Text Key285982755
Report Number1119421-2022-00339
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberACU0T0
Device Lot Number15229090
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/23/2022 Patient Sequence Number: 1
Treatment
PROVISC
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