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 Codes	Device Difficult to Setup or Prepare (1487); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Eye Injury (1845); Visual Disturbances (2140)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
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 cataract surgery with intraocular lens (iol) implantation, implant was stuck in the injector, one haptic came out while the other was stuck in the eye.The surgeon had to remove the implant and make a larger incision.Then placed another implant.There was no further impact to the patient.
Additional Manufacturer Narrative
Additional information was provided in a1, a2, a3.A, b3, b5, d10, and h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that, the incision had to be enlarged to explant the implant, as the broken proximal haptic remained stuck to the injector¿s plunger.The enlarged incision required suturing, which induced astigmatism.The patient was under general anesthesia.The procedure time was extended, but no further consequences were reported.The procedure was completed with company similar model iol.
Additional Manufacturer Narrative
On initial mdr submitted the product code should be a0502 instead of a2201.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: 22783552
• Report Number: 9612169-2025-01637
• Device Sequence Number: 13273246
• Product Code: MJP
• UDI-Device Identifier: 00380652400336
• UDI-Public: (01)00380652400336(17)271003(11)231005(10)25716482
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNA0T6
• Device Lot Number: 25716482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/01/2025; 09/25/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/24/2025; 10/17/2025
• Date Device Manufactured: 10/05/2023
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; DUOVISC VISCOELASTIC SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male