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

Model Number	CNA0T0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
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 healthcare professional reported that, during intraocular lens implantation surgery, the haptic cracked when the lens was pushed out.Additional information was received stating that, the front haptic did not fold nicely when the lens was pushed out and the lens was left in the eye, only the small piece of haptics was removed and discarded.The diagnosis of the patient was good, the lens was centered well, although a small piece of the haptic was missing.Thee prognosis was very good.There was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in h.11.The product was not returned for analysis.Only photo was returned.The tip of a broken haptic was observed on the returned photo.Provided photo shows what appears to be a tip of a haptic against unknown background.Based on our observation of the attached photo, there appears to be a tip of a haptic against unknown background.A definitive determination of the reported complaint cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.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: 22174733
• Report Number: 9612169-2025-01206
• Device Sequence Number: 7829519
• Product Code: HQL
• UDI-Device Identifier: 00380652396448
• UDI-Public: (01)00380652396448(17)270508(11)240509(10)25852299
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: CNA0T0
• Device Lot Number: 25852299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/25/2025
• Date Device Manufactured: 05/09/2024
• 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
• Patient Sex: Unknown