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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Capsular Bag Tear (2639)
Event Date 03/24/2022
Event Type  Injury  
Manufacturer Narrative
The used device and the lens were returned inside a self sealing non company blue pouch in a biohazard bag. The plunger lock and lens stop were removed. The plunger was oriented correctly. Viscoelastic was observed in the device. The plunger was retracted to mid-nozzle. There was no damage observed to the device. The lens was scraped. The optic was cut into two portions, typical in appearance to damage created to facilitate removal from the eye. A qualified viscoelastic was indicated. The product investigation could not identify a root cause for the reported complaint. The removed lens and the used device were returned. It is unknown if the product contributed to the event. No damage was observed to the device. The plunger was retracted. The plunger position in relation to the lens during advancement cannot be determined. It cannot be confirmed if the lens was in a proper position for advancement during delivery. Information was provided in the file that the 18. 0 diopter lens was removed and replaced with an another company model 18. 0 diopter lens. The manufacturer internal reference number is: (b)(4).
 
Event Description
A non healthcare professional reported that during implantation of an intraocular lens (iol) the capsule tear was noted after lens was implanted. The lens was removed and replaced with another lens. The capsular bag was not intact. Additional information was requested.
 
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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
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key14201639
MDR Text Key290041960
Report Number1119421-2022-00843
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
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberAU00T0
Device Lot Number15318269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2022
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/26/2022 Patient Sequence Number: 1
Treatment
DISCOVISC; ORA SYSTEM
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