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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number AU00T0
Device Problem Firing Problem (4011)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2018
Event Type  malfunction  
Manufacturer Narrative
A sample product was not returned for analysis. Product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. There are no other complaints in the lot. Additional information was requested. The manufacturer internal reference number is: (b)(4).
 
Event Description
A facility representative reported that during an intraocular lens (iol) implant procedure, the lens would not deploy. The product did come into contact with the patient, but there was no harm reported. 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, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8258167
MDR Text Key133718743
Report Number1119421-2019-00082
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,Followup
Report Date 11/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model NumberAU00T0
Device Lot Number12648117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2018
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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