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

Model Number	CNA0T3
Medical Device Problem Codes	Failure to Fold (1255); Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, haptic twisted, lens did not fold properly.Additional information was requested.
Additional Manufacturer Narrative
Correction information was provided in d.4.The manufacturer internal reference number is: (b)(4).

• 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: 20096383
• Report Number: 9612169-2024-00832
• Device Sequence Number: 20749245
• Product Code: MJP
• UDI-Device Identifier: 00380652398800
• UDI-Public: (01)00380652398800(17)271015(11)231017(10)25733395
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: CNA0T3
• Device Lot Number: 25733395
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 11/22/2024
• Date Device Manufactured: 10/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown