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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 SN6AT5
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
Product evaluation: the product was returned. Solution is dried on the lens. Both haptics are slightly bent in the gusset area. The optic is cut into two portions, typical of an insertion and removal. Power and resolution testing could not be conducted due to the extensive optic damage. The customer indicated the use of a qualified cartridge and a non-qualified viscoelastic. The product investigation could not identify a root cause for the reported complaint. Power and resolution testing could not be conducted due to the extensive optic damage. The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
Product evaluation: the product was not returned for analysis. Product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. There have been no other similar complaints reported in the lot number. Additional information has been requested. The manufacturer internal reference number is: (b)(4).
 
Event Description
A nurse reported that a lens was removed due to wrong power following an intraocular lens (iol) implant procedure. Additional information has been requested.
 
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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
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6807803
MDR Text Key109386392
Report Number1119421-2017-01060
Device Sequence Number1
Product Code MJP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2019
Device Model NumberSN6AT5
Device Catalogue NumberSN6AT5.170
Device Lot Number12296310
Other Device ID Number00380652250931
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2014
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: 08/21/2017 Patient Sequence Number: 1
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