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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SN6AT5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
 
Event Description
A consumer reported that following bilateral intraocular lens (iol) implant procedures she has experienced discomfort and has not gotten satisfaction from the implants.Additional information was provided by the consumer that she had a yag laser procedure.She reports that she has also experienced dry eyes, double vision and eye strain since the implantation of the lenses.She has had several pairs of glasses that just don't help.She reports that the correction was worth it.There are two medical device reports associated with this patient.This report is for the right eye.
 
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Brand Name
ACRYSOF IQ TORIC SINGLEPIECE IOL
Type of Device
LENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key10341271
MDR Text Key200965040
Report Number1119421-2020-01075
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 Other
Type of Report Initial
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2015
Device Model NumberSN6AT5
Device Catalogue NumberSN6AT5.215
Device Lot Number12015362
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/07/2020
Initial Date FDA Received07/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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