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

Model Number	CNA0T4
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A pharmacist reported that during intraocular lens (iol) procedure, the lens blocked in incision during injection (high diopter of the lens).The lens was removed with forceps and the surgery was completed in the same procedure with non-preloaded backup implant with no patient impact.Additional information was requested, but no further information is available.
Additional 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).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint could not be confirmed.The device was received in a pouch inside the carton.The plunger is fully advanced outside of the nozzle tip.Solution is dried in the device.No damage observed.The lens is returned outside of the device adhered to the lens bay door.Solution is dried on the intraocular lens (iol).The product investigation could not identify the root cause for the reported complaint "implant blocked in incision during injection".The instructions for use (ifu) instructs to: "insert the nozzle tip into the incision as far as needed to facilitate lens implantation, using the depth guard as the insertion limit, and aim the nozzle tip at the anterior capsule opening.Advance the plunger by depressing the speed control lever.Maintain adequate pressure to ensure the nozzle tip remains in the incision".Based on the results from the product history record, the products met release criteria.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: 20748139
• Report Number: 9612169-2024-01211
• Device Sequence Number: 8297623
• Product Code: MJP
• UDI-Device Identifier: 00380652399449
• UDI-Public: (01)00380652399449(17)280319(11)240321(10)25811910
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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: CNA0T4
• Device Lot Number: 25811910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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: Female