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

Model Number	CNA0T6
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A pharmacist reported that, during intraocular lens implantation surgery, the haptic was bent.The lens was in contact with the patient's eye.The lens was then explanted and replaced with another back up lens during the same procedure.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis and the reported complaint could not be observed.Intra ocular lens (iol) was returned outside of the device.The device was received loose in a plastic bag inside the product carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger has been fully advanced outside the nozzle.No damage observed.The lens was returned outside of the device.Solution is dried on the iol, no damage observed to the haptics.The optic is cracked/fractured.The product investigation could not identify the root cause for the reported complaint "twisted back leg (haptic), bent implant, in/out" as the lens was returned outside of the device.Due to this, we are unable to confirm the lens and the plunger position for advancement and determine a root cause.The product was returned for analysis and no damage was observed to the haptics.Folding issues may occur with the trailing haptic: ¿ if the lens has become misaligned in the lens bay during the manufacturing process.¿ due to the use of a non-qualified viscoelastic.Material properties of non-qualified ophthalmic viscosurgical device (ovd)s may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.¿ if inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly.¿ if the operating room temperature is too high (greater 23 degree celsius / 73 degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may create the reported event.The directions for use (dfu) instructs: "visually inspect the lens to determine the position of the leading and trailing haptics (refer to figure 7).Verify that the plunger is in contact with the trailing optic edge." 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: 22235323
• Report Number: 9612169-2025-01241
• Device Sequence Number: 9147713
• Product Code: MJP
• UDI-Device Identifier: 00380652400350
• UDI-Public: (01)00380652400350(17)280220(11)240222(10)25803861
• 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): 08/28/2025

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: CNA0T6
• Device Lot Number: 25803861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC VISCOELASTIC SYSTEM.
• Patient Age: 79 YR
• Patient Sex: Female