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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 Problems Unexpected Therapeutic Results (1631); Improper or Incorrect Procedure or Method (2017)
Patient Problems Scarring (2061); Visual Disturbances (2140)
Event Date 03/07/2018
Event Type  Injury  
Manufacturer Narrative
A sample 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 are no other complaint in the lot. Additional information was requested. (b)(4).
 
Event Description
A consumer reported that after having had an intraocular lens (iol) implanted, she can't see distances like she did prior to surgery. She can't see road signs and has difficulty going to the grocery store. A retina specialist told her that she had the "wrong" lens in her eye. She was prescribed a contact lens to wear, but has difficulty in handling it. She also has prescribed glasses, but does not like them. She was informed that she cannot have the lens exchanged due to too much "scar tissue" on her eye. The consumer did not give her surgeon's data and did not want him contacted for more data.
 
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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
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7728309
MDR Text Key115297957
Report Number1119421-2018-01026
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 07/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2019
Device Model NumberSN6AT3
Device Catalogue NumberSN6AT3.200
Device Lot Number12303784
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2014
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: 07/27/2018 Patient Sequence Number: 1
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