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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: product evaluation: complaint history and product history records were reviewed and documentation indicated the product met release criteria. There have been no other complaints reported in the lot number. Root cause has not been identified. The manufacturer internal reference number is: (b)(4).
 
Event Description
A healthcare professional reported during a cataract with intraocular lens (iol) implant procedure; the lens was placed in the eye upside down. The lens was "1/2 inserted & removed". There was no patient impact reported. Additional information has been 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
8175514979
MDR Report Key11302412
MDR Text Key232338903
Report Number1119421-2021-00263
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 other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAU00T0
Device Lot Number12755728
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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