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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 SN6AT4
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Insufficient Information (4580)
Event Date 06/20/2022
Event Type  malfunction  
Event Description
A facility representative reported that during an intraocular lens (iol) implant procedure, the surgeon found that iol had lens material hanging off the edge of the iol. The material was removed by surgeon with forceps. The removed pieces were not saved. Additional information has been requested.
 
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. Root cause has not been identified. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
 
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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 Key15051748
MDR Text Key296134163
Report Number1119421-2022-01577
Device Sequence Number1
Product Code MJP
UDI-Device Identifier00380652250443
UDI-Public00380652250443
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 Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSN6AT4
Device Catalogue NumberSN6AT4.210
Device Lot Number15241534
Was Device Available for Evaluation? No
Date Manufacturer Received07/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/19/2022 Patient Sequence Number: 1
Treatment
UNSPECIFIED FORCEPS
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