MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCAET0
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2025
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-healthcare professional reported that during intraocular lens (iol) implantation, the leading haptic was twisted into a reverse question mark shape and unfolded along the posterior capsule.The patient got replaced with another lens on the same day.Addition information was requested and no further information was available.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 22372617
• Report Number: 9612169-2025-01322
• Device Sequence Number: 19936761
• Product Code: POE
• UDI-Device Identifier: 00380652406802
• UDI-Public: (01)00380652406802(17)280414(11)240416(10)25835157
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: CCAET0
• Device Lot Number: 25835157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 07/01/2025
• Date Device Manufactured: 04/16/2024
• 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: VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown