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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number AU00T0
Device Problems IOL (Intraocular Lens) Implant; Break
Event Date 10/27/2015
Event Type  Injury  
Manufacturer Narrative

A sample is in transit to manufacturing site. 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. Additional information has been requested but not received to date. (b)(4).

 
Event Description

A doctor of ophthalmology reported that a lens broke into pieces during an intraocular lens (iol) implant. Additional information was received. Once the lens was in the anterior chamber, the haptic broke. The edge of the lens was damaged too. The lens was removed from the eye and another lens was implanted. The event caused a 1-1. 10 hour delay and an important loss of endothelial cells. According to the reporter, the event was caused by the plunger. Additional information has been requested but not received to date.

 
Manufacturer Narrative

Evaluation summary: the complete device was not returned. A portion of the lens was returned in solution inside a bss 15ml bottle. The optic portion was torn/split with a broken haptic. Product history records were reviewed and the documentation indicated the product met release criteria. Two viscoelastics were indicated, only one is qualified for this device. It is unknown if the approved component of the indicated viscoelastic was used. The product investigation could not identify a root cause because the device was not completely returned for evaluation. It is unknown if a qualified viscoelastic was used. As stated in the directions for use (dfu), only qualified viscoelastics must be used in conjunction with the device. All other viscoelastics are not qualified for use. Lens delivery performance may be negatively affected when using non-qualified viscoelastics leading to lens delivery issues and /or damage. The use of non-qualified viscoelastics is considered a failure to follow the dfu and is not recommended under any circumstance.

 
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Brand NameACRYSOF IQ SINGLEPIECE IOL W/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
eddie darton, md, jd
6201 south freeway
mail stop ab2-6
fort worth , TX 76134
8175686660
MDR Report Key5261312
Report Number1119421-2015-06724
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/01/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2017
Device MODEL NumberAU00T0
Device Catalogue NumberAU00T0.240
Device LOT Number12384562
OTHER Device ID Number00380652358354
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/01/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/03/2015
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: 12/02/2015 Patient Sequence Number: 1
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