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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Eye Injury (1845); Vitrectomy (2643)
Event Date 10/10/2018
Event Type  Injury  
Manufacturer Narrative
The lens only was returned for analysis. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. Results from the product history record review indicated the product met release criteria. There have been no other complaints reported in the lot number. Additional information was requested. (b)(4).
 
Event Description
A nurse reported that during an intraocular lens (iol) implant procedure, there was a capsular tear associated with the delivery of a lens with a straight leading haptic. An anterior vitrectomy was performed and a back up lens was placed in sulcus. 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
8176152230
MDR Report Key8083315
MDR Text Key127535453
Report Number1119421-2018-01618
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
Type of Report Initial,Followup
Report Date 01/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model NumberAU00T0
Device Lot Number12613638
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2018
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: 11/19/2018 Patient Sequence Number: 0
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