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 Code	Failure to Fold (1255)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/10/2025
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 nurse reported that during an intraocular lens implant procedure large posterior capsular tear due to incorrect bending of the initial implant.The lens removed during initial procedure and company lens was placed in the sulcus without any particular incident.At the end of the procedure, there was no sign of vitreous encapsulation.Patient was discharged the same day.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in b.5., d.9., d.10., h.3., h.6.And h.11.The product was returned for analysis and the reported complaint could not be confirmed.The device was received loose in the product carton.The lock out assembly has been removed.Viscoelastic is observed in the device.The plunger is partially advanced outside the nozzle tip.The plunger tip is crushed.The plunger part outside the nozzle tip is also bent, this most likely was caused during the sample preparation shipment back to the manufacturing site.The lens was returned outside of the device wrapped in a transparent adhesive tape.The optic is cut in the centre.The complainant states the use of eyefill as viscoelastic, which is not qualified to be used with the associated product.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow instructions for use (ifu), as the customer states the use of non-qualified viscoelastic.The use of an unqualified ovd may cause damage to the lens, inconsistent folding outcomes and potential complications during the implantation process.In addition to the above, during sample evaluation, plunger was observed not fully advanced, this may cause lens not to be able to release correctly from the nozzle causing potential implantation issues.As per the ifu, the lens should be inspected at the pause location prior implantation.The ifu states: visually inspect the lens to determine the position of the leading and trailing haptics.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).
Event or Problem Description
Additional information has been received and stated that the patient had to undergo further surgery for vitreous incarceration in the counter puncture following cataract surgery, during which posterior capsular rupture had occurred.There was no vitreous leakage at the end of the first procedure.This operation consisted of a posterior vitrectomy, washing of the anterior chamber, and dissection of the posterior hyaloid membrane.This second procedure was took place on (b)(6) 2025.The patient was doing well, and the second operation was uneventful.

• 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: 21994515
• Report Number: 9612169-2025-01025
• Device Sequence Number: 19988184
• Product Code: MJP
• UDI-Device Identifier: 00380652399951
• UDI-Public: (01)00380652399951(17)281208(11)241210(10)25955983
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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: CNA0T5
• Device Lot Number: 25955983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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: EYEFILL OVD
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown