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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 SN6AT3
Device Problems Material Opacification (1426); Device Contamination with Chemical or Other Material (2944)
Patient Problems Dry Eye(s) (1814); Headache (1880); Burning Sensation (2146)
Event Date 04/04/2022
Event Type  malfunction  
Manufacturer Narrative
A sample device was not returned for analysis. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. There have been no other complaints reported in the lot number. Root cause has not been identified. The manufacturer internal reference number is: (b)(4).
 
Event Description
A consumer reported following the intraocular lens implantation she started noticing a feeling of something in eye or it's scratched, almost like a burning, a really weird feeling. The patient reported that the feeling gets really bad, and gives horrible headaches. The patient reported that she also keeps getting cloudiness over that eye, which makes it difficult to see at night. Additional information has been requested and received stating the quality issue was not due to the lens but is most likely due to dry eye. There was no harm to the patient and the prognosis was good. The patient was not hospitalized for the event.
 
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Brand NameACRYSOF IQ TORIC SINGLEPIECE IOL
Type of DeviceLENS, 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
8007579780
MDR Report Key14346736
MDR Text Key291366890
Report Number1119421-2022-00994
Device Sequence Number1
Product Code MJP
UDI-Device Identifier00380652249638
UDI-Public00380652249638
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 Non-Healthcare Professional
Type of Report Initial
Report Date 05/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSN6AT3
Device Catalogue NumberSN6AT3.070
Device Lot Number15185607
Was Device Available for Evaluation? No
Date Manufacturer Received04/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/10/2022 Patient Sequence Number: 1
Treatment
MONARCH II IOL DELIVERY SYSTEM, INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
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