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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 Unintended Movement (3026)
Patient Problems Rupture (2208); Capsular Bag Tear (2639)
Event Date 06/12/2018
Event Type  Injury  
Manufacturer Narrative
A sample product was not received 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. (b)(4).
 
Event Description
An operating room director reported that during an intraocular lens (iol) implant procedure, the lens shot out causing a ruptured posterior capsule. A vitrectomy was performed and the surgeon realized that the eye could not provide capsular support for a posterior chamber iol, so an anterior chamber lens was implanted. The incision was closed with nylon suture.
 
Manufacturer Narrative
This supplement is being filed to correct the value to adverse event and product problem. The manufacturer internal reference number is: (b)(4).
 
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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
bryan blake
rheinstrasse 8
teltow D-145-13
GM   D-14513
8176152230
MDR Report Key7706048
MDR Text Key114558979
Report Number1119421-2018-00958
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model NumberAU00T0
Device Lot Number12585744
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/20/2018 Patient Sequence Number: 1
Treatment
DUOVISC
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