MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNA0T5
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Product Quality Problem (1506)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported a defective iol.
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information provided in b.3.And e.4.On the initial medical device report (mdr), the event date known field was marked as "ni." it should have been marked as "yes." additional information provided in b.5.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, when advancing the lens the physician noted that one haptic was not in order.There was no patient contact with the deivce.

• Brand Name: CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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 Key: 23497596
• Report Number: 9612169-2025-02238
• Device Sequence Number: 9106625
• Product Code: MJP
• UDI-Device Identifier: 00380652399821
• UDI-Public: (01)00380652399821(17)271114(11)231116(10)25751188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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 Number: CNA0T5
• Device Lot Number: 25751188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/08/2025
• Date Device Manufactured: 11/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown