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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 SN6AT3
Device Problem Therapeutic or Diagnostic Output Failure
Event Type  Injury  
Manufacturer Narrative

Evaluation summary: the product was returned for analysis. 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. Results from the product history record review indicated the product met release criteria. There have been no other complaints reported in the lot number. Attempts have been made to obtain additional information by phone and email. A completed questionnaire was not received. (b)(4).

 
Event Description

A customer reported that following an intraocular lens (iol) implant procedure, the patient experienced positive dysphotopsia. The lens was removed and replaced in a second procedure. Additional information has been requested.

 
Manufacturer Narrative

Product evaluation: the sample was returned with solution and lens damage. The optic was torn into two pieces with additional optic damage. The root cause could not be determined for the reported complaint. The optic was damaged and torn into pieces. While we are unable to determine the root cause of the lens damage, our observation reasonably suggests that it is not manufacturing related. Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling. (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 Key5273957
Report Number1119421-2015-06763
Device Sequence Number1
Product CodeMJP
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2019
Device MODEL NumberSN6AT3
Device Catalogue NumberSN6AT3.210
Device LOT Number12339030
OTHER Device ID Number00380652249911
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/03/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/03/2014
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: 12/08/2015 Patient Sequence Number: 1
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