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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

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ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS Back to Search Results
Model Number CNA0T0
Device Problem Defective Component (2292)
Patient Problem Insufficient Information (4580)
Event Date 03/01/2024
Event Type  malfunction  
Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is:(b)(4).
 
Event Description
A facility representative reported that during an intraocular lens (iol) implant procedure, the plunger was defective and the lens was implanted and removed.Additional information was requested, but no further information is available.
 
Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint could not be determined as no sample was returned for analysis.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI  00000
Manufacturer (Section G)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI   00000
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key18992774
MDR Text Key338883191
Report Number9612169-2024-00267
Device Sequence Number1
Product Code HQL
UDI-Device Identifier00380652393751
UDI-Public00380652393751
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P190018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/24/2024
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
Device Operator Health Professional
Device Model NumberCNA0T0
Device Lot Number25708813
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/04/2024
Initial Date FDA Received03/28/2024
Supplement Dates Manufacturer Received05/27/2024
Supplement Dates FDA Received06/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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