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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ANTERIOR CHAMBER PMMA SINGLEPIECE IOL; INTRAOCULAR LENS
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ALCON RESEARCH, LLC - HUNTINGTON ANTERIOR CHAMBER PMMA SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number MTA4U0
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Zonular Dehiscence (2698)
Date of Event 06/07/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
The non healthcare professional reported that an iol reply card was received with report of implanted/explanted.
 
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Brand Name
ANTERIOR CHAMBER PMMA SINGLEPIECE IOL
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key12244462
Report Number1119421-2021-01490
Device Sequence Number20019149
Product Code HQL
UDI-Device Identifier00380652535731
UDI-Public00380652535731
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P880087
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) 07/29/2021
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
Operator of Device Health Professional
Device Expiration Date07/31/2022
Device Model NumberMTA4U0
Device Catalogue NumberMTA4U0.120
Device Lot Number12562280
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/02/2021
Initial Report FDA Received Date07/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age81 YR
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