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

Model Number	CCA0T0
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2025
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 non-health care professional reported during intra ocular lens (iol) implant procedure, the surgeon noticed leading haptic presented posterior to optic after implanting into the eye.They were freed with a unspecified instrument.The lens was explanted during initial procedure.Additional information has been requested.

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL WITH 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: 22203211
• Report Number: 9612169-2025-01228
• Device Sequence Number: 6887743
• Product Code: HQL
• UDI-Device Identifier: 00380652397247
• UDI-Public: (01)00380652397247(17)280706(11)240708(10)25883399
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: CCA0T0
• Device Lot Number: 25883399
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/13/2025
• Date Device Manufactured: 07/08/2024
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.; UNSPECIFIED INSTRUMENT.
• Patient Age: 83 YR
• Patient Sex: Unknown