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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS
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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number MA50BM
Medical Device Problem Code Material Opacification (1426)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 05/30/2003
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.Additional information was requested and received.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A nurse reported that an intraocular lens (iol) was explanted due to lens opacification.Additional information was requested and received.
 
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Brand Name
ACRYSOF MULTIPIECE IOL
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key12050783
Report Number1119421-2021-01260
Device Sequence Number19748399
Product Code HQL
UDI-Device Identifier00380650698414
UDI-Public00380650698414
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P930014
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 06/23/2021
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? No
Operator of Device Health Professional
Device Model NumberMA50BM
Device Catalogue NumberMA50BM.140
Device Lot NumberASKU
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/03/2021
Initial Report FDA Received Date06/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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