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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 SN6AT4
Device Problems Device Inoperable; Improper or Incorrect Procedure or Method; Component or Accessory Incompatibility
Event Date 10/01/2015
Event Type  Injury  
Manufacturer Narrative

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. The iol product history records were reviewed and documentation indicates the product met release criteria. There have been no other complaints reported in the lot number. Attempts have been made to obtain additional information. A completed questionnaire was received on 11/09/2015. (b)(4).

 
Event Description

A facility representative reported that an intraocular lens (iol) had a haptic failure. In a follow up, a facility director indicated that the haptic failure was noted six weeks after initial implantation and was then exchanged approximately one month later. The director reported an unapproved lens/handpiece/viscoelastic combination used during iol implantation.

 
Manufacturer Narrative

A sample lens was not received for analysis. The product investigation could not identify a root cause. Information was provided which indicated an unapproved handpiece with an unapproved viscoelastic were used. The use of unapproved products may result in lens delivery difficulties or lens damage. (b)(4).

 
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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 Key5268465
Report Number1119421-2015-06740
Device Sequence Number1
Product CodeMJP
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/04/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date12/31/2018
Device MODEL NumberSN6AT4
Device Catalogue NumberSN6AT4.235
Device LOT Number12270507
OTHER Device ID Number00380652250498
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/03/2014
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: 12/04/2015 Patient Sequence Number: 1
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