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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS
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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number SA60AT
Medical Device Problem Codes Material Twisted/Bent (2981); Scratched Material (3020)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/02/2021
Type of Reportable Event Malfunction
Additional 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 has been one other complaint reported in the lot number.  additional information has been requested.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A non-healthcare professional reported that during implantation of an intraocular lens (iol) was bent & scratched.Additional information was requested.
 
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Brand Name
ACRYSOF SINGLEPIECE IOL
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key12173039
Report Number1119421-2021-01379
Device Sequence Number1631942
Product Code HQL
UDI-Device Identifier00380652555807
UDI-Public00380652555807
Combination Product (Y/N)N
Initial Reporter StateDC
Initial Reporter CountryUS
PMA/510(K) Number
P930014
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/31/2024
Device Model NumberSA60AT
Device Catalogue NumberSA60AT.200
Device Lot Number12741822
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/22/2021
Initial Report FDA Received Date07/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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