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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 Problems Detachment Of Device Component (1104); Malposition of Device (2616)
Patient Problems Visual Impairment (2138); Device Embedded In Tissue or Plaque (3165)
Event Date 11/14/2017
Event Type  malfunction  
Manufacturer Narrative
The device with the trailing haptic was returned. The plunger is oriented correctly. Viscoelastic is observed in the device. The plunger has been retracted to mid-nozzle. The broken trailing haptic is in the nozzle tip with the distal portion oriented toward the tip. The lens remains implanted. Product history records were reviewed and the documentation indicated the product met release criteria. Viscoelastic was not provided. The root cause for the broken haptic cannot be determined. The plunger was retracted. The plunger position in relation to the broken haptic during advancement cannot be determined. The haptic position may indicate the plunger was not fully advanced. If the plunger is not fully advanced the trailing haptic may not release properly from the device. It is unknown if a qualified viscoelastic was used. Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes. The manufacturer internal reference number is:(b)(4).
 
Manufacturer Narrative
The device was received by a company representative and is in transit to the manufacturing site for investigation. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. 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. The manufacturer internal reference number is: (b)(4).
 
Event Description
A facility representative reported that when an intraocular lens (iol) was injected into a patient's eye, a haptic was noted to be amputated. Although lens was positioned and left implanted, the lens decentered but still encompasses the entire undilated pupil area. The patient does report occasional diplopia. The patient remains under observation and if the lens decenters further, it would be replaced. Additional information was requested and received.
 
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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 Key7141433
MDR Text Key120432733
Report Number1119421-2017-01455
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model NumberAU00T0
Device Lot Number12515570
Other Device ID Number00380652358316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2017
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: 12/22/2017 Patient Sequence Number: 1
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