MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CNA0T0
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	10/01/2024
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 healthcare professional reported that during an intraocular lens (iol) implantation procedure, implantation failure occurred though incision enlargement has been done.The lens was subsequently loaded in non-preloaded cartridge.When the implant was deployed in the eye, half of the upper haptic was broken and removed.The implant was positioned normally, but it was decided to leave it in place so as not to be deleterious if the implant was removed as the lens diopter was high.Additional information was received stating as per the patient's diopter and eye type (small with corneal degeneration), surgeon decided to leave it in, as lens was stable.On post-op day 7, the implant was centered.
Additional Manufacturer Narrative
Additional information was added in h.11.The root cause for the reported complaint "incision enlargement" could not be determined.The reported complaint is lacking in relevant information such as what was the issue with the failed implementation of the lens using company device.It was reported that implantation failed despite an enlarged incision.The 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".It is unclear whether the reporter suspects a product issue or was the event due to use error.In addition to the above, the complainant indicates that the iol was removed from the autonome device and manually reloaded into a cartridge when the haptic breakage occurred.The root cause for the reported "broken haptic" appears to be related to user error - autonome is a pre-loaded device and the lens must not be removed from it and reloaded into a cartridge and can only be used with the autonome device.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 IOL WITH THE AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 20570641
• Report Number: 9612169-2024-01109
• Device Sequence Number: 8003089
• Product Code: HQL
• UDI-Device Identifier: 00380652396516
• UDI-Public: (01)00380652396516(17)270107(11)240109(10)25773808
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/06/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25773808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/06/2025
• Date Device Manufactured: 01/09/2024
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female