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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS

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ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS Back to Search Results
Model Number SY60WF
Device Problem Scratched Material (3020)
Patient Problem Insufficient Information (4580)
Event Date 03/14/2024
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 pharmacist reported that during an intraocular lens (iol) implant procedure, mark on the lens detected during preparation.The implant was changed.Additional information has been requested.
 
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Brand Name
CLAREON IOL
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 Key19123940
MDR Text Key340352833
Report Number9612169-2024-00336
Device Sequence Number1
Product Code HQL
UDI-Device Identifier00380652251518
UDI-Public00380652251518
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P190018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/17/2024
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 NumberSY60WF
Device Lot Number25580216
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/21/2024
Initial Date FDA Received04/17/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/02/2023
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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