Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS Back to Search Results
Model Number CNA0T0
Medical Device Problem Code Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/17/2026
Type of Reportable Event Malfunction
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
Common Device Name
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 Key25815768
Report Number9612169-2026-01611
Device Sequence Number10602238
Product Code HQL
UDI-Device Identifier00380652393775
UDI-Public(01)00380652393775(17)280611(11)250613(10)26051972
Combination Product (Y/N)N
Initial Reporter CountryTH
PMA/510(K) Number
P190018
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/14/2026
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 Model NumberCNA0T0
Device Lot Number26051972
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2026
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/19/2026
Initial Report FDA Received Date07/14/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured06/13/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient SexUnknown
-
-