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 Codes	Particulates (1451); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during a cataract surgery involving an intraocular lens (iol) implant procedure, a scratch or foreign material adhered to the surface of the lens after it was implanted.The foreign material could not be removed by aspiration with the irrigation/aspiration (i/a).Additional information received stating that there was no patient harm.
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).
Additional Manufacturer Narrative
The intraocular lens (iol) was not returned for analysis and the reported complaint could not be observed.The device was returned in a clear plastic bag.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger has been advanced outside the nozzle tip.The plunger tip is bent/damaged, this is most likely due to being returned bagged and loose in the carton.No iol returned.No reported "foreign material" returned.Photo review: video show cataract removal.The nozzle comes into view and the tip was inserted into the incision the haptics appeared to be tucked in the optic fold.The iol was advanced into the eye and begins to unfold.A metal surgical instrument was used to position the iol.A white colored material is observed at the periphery of the optic.Attempts are made to remove the material with a surgical tool.It is unclear from the video if the material is removed.The product investigation could not identify the root cause for the reported complaint "scratch or foreign material adhered to surface of lens" as neither the lens or the reported material was returned.Only the device was returned for evaluation.Due to the lack of returned sample, we are unable to verify if the product contributed to the event.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: 20556807
• Report Number: 9612169-2024-01092
• Device Sequence Number: 21081801
• Product Code: MJP
• UDI-Device Identifier: 00380652399364
• UDI-Public: (01)00380652399364(17)270611(11)230613(10)25660224
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: CNA0T4
• Device Lot Number: 25660224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/27/2024
• Date Device Manufactured: 06/13/2023
• 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.
• Patient Sex: Unknown