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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 10/31/2017
Event Type  malfunction  
Manufacturer Narrative
A sample device was not returned for analysis. The lens remains implanted. Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation. Root cause has not been identified. Additional information was requested. (b)(4).
 
Event Description
A technician reported that after an intraocular lens (iol) was implanted, it was determined that there was an unexpected refractive outcome and one of the iol haptics was positioned outside of the capsular bag in the sulcus region of the eye. Additional information was 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 Key7075490
MDR Text Key93621612
Report Number1119421-2017-01379
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 other
Reporter Occupation
Type of Report Initial
Report Date 12/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSN6AT3
Device Catalogue NumberSN6AT3.200
Device Lot NumberASKU
Other Device ID Number00380652249898
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 Received11/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/01/2017 Patient Sequence Number: 1
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