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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 Use of Device Problem (1670)
Patient Problem Capsular Bag Tear (2639)
Event Date 11/16/2017
Event Type  Injury  
Manufacturer Narrative
Product evaluation: viscoelastic was not provided; it is unknown if a qualified product was used. The product investigation could not identify a root cause. Material properties of non-qualified ovds (ophthalmic viscosurgical devices) may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes. (b)(4).
 
Event Description
Additional information was received, indicating that after injection of the implant, the surgeon noticed that the implant was folded in the eye.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Additional information was received, indicating that after injection of the implant, the surgeon noticed that the implant was "crumpled" in the eye. In a returned questionnaire, the implanting physician confirmed that sudden release of the iol from the preloaded cartridge led the central posterior capsule tear. It was also reported that anterior vitrectomy was performed as vitreous presented. Implantation of a posterior chamber lens into the sulcus was also performed after removal of the first lens through an enlarged incision. The incision was then sutured with two stitches. The surgeon confirmed that although the patient had strong myopia, there was no capsular damage noted after the phaco step and before implantation of the lens. There has been no sign of retinal detachment.
 
Manufacturer Narrative
Product evaluation: the product was not returned for analysis. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. There have been no other complaints reported in the lot number. A root cause has not been identified. (b)(4).
 
Event Description
A facility representative reported that during a cataract removal with intraocular lens (iol) implant procedure, a folding issue led to a capsular bag rupture, as the iol left the injector too quickly (quick release). The iol was cut to be removed from the patient's eye, and a multipiece iol was placed in the sulcus instead. It was noted that the injector and iol involved are not available for return. Additional information has been 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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7141401
MDR Text Key110213543
Report Number1119421-2017-01427
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model NumberAU00T0
Device Lot Number12438073
Other Device ID Number00380652358026
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 Received02/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2016
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: 12/21/2017 Patient Sequence Number: 1
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