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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SN6AT8
Device Problem Degraded
Event Date 09/01/2015
Event Type  Injury  
Manufacturer Narrative

Evaluation summary: product history and batch records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. The device was not returned for evaluation. There have been no other complaints reported in the lot number. Attempts have been made to obtain additional information by phone and fax. A completed questionnaire was not received. (b)(4).

 
Event Description

Following intraocular lens (iol) implant surgery a surgeon reported the lens to be explanted due to blurry vision.

 
Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

 
Event Description

Following intraocular lens (iol) implant surgery a surgeon reported a patient to complain of blurry vision. The lens was exchanged for another lens of a different model. The device was not returned for evaluation.

 
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Brand NameACRYSOF IQ TORIC SINGLEPIECE IOL
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
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 Key5196117
Report Number1119421-2015-06524
Device Sequence Number1
Product CodeMJP
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date01/31/2017
Device MODEL NumberSN6AT8
Device Catalogue NumberSN6AT8U165
Device LOT Number12126308
OTHER Device ID Number00380652277969
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 Received11/03/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/19/2012
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: 11/02/2015 Patient Sequence Number: 1
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