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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 Sticking (1597)
Patient Problems Corneal Abrasion (1789); High Blood Pressure/ Hypertension (1908)
Event Date 12/13/2017
Event Type  Injury  
Manufacturer Narrative
The device and the lens were returned separated. The plunger is oriented correctly. Viscoelastic is observed in the device. The plunger has been fully advanced outside of the nozzle tip. A piece of the broken haptic is observed pinned on top of the plunger. The lens was returned wrapped in gauze. Viscoelastic is observed on the lens. One haptic is broken-gusset and distal area (distal portion in device). The lens has been cut into three pieces. Product history records were reviewed and the documentation indicated the product met release criteria. A qualified viscoelastic was indicated. The root cause for the broken haptic could not be determined. The broken haptic portion is on top of the plunger pinned against the upper tip area. The position of the broken haptic portion indicates it was not in a proper position for advancement per the provided diagrams in the dfu. (b)(4).
 
Manufacturer Narrative
Complaint history and product history records were reviewed and documentation indicated the product met release criteria. There are no other complaints in the lot. The device was received by a company representative and is in transit to the manufacturing site for investigation. Investigation including root cause analysis will be completed. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. Additional information was requested and received. (b)(4).
 
Event Description
A surgeon reported that during an intraocular lens (iol) implantation procedure, the trailing haptic became caught in the injector and tore off during the insertion of the lens into the eye. With difficulty and extended time the lens was cut and removed from the eye and another lens was implanted. Due to the extended time required for event management, the patient's blood pressure increased and the his cornea was scratched due to frequent eye movements. The surgeon felt the use of the device was stressful due to many "check points" during use. In a follow up, the surgeon indicated that the corneal endothelial cell issue was not serious and patient was recovering. Additional data was provided indicating that the planned percentage use of a glucocorticoid medication was increased from. 01% to. 1% due to the event. The patient's vision increased from. 2 (20/100) to. 7 (20/30) within the first postoperative week.
 
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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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7173733
MDR Text Key110207890
Report Number1119421-2018-00030
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Model NumberAU00T0
Device Lot Number12481726
Other Device ID Number00380652381987
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2016
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: 01/08/2018 Patient Sequence Number: 1
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