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

Model Number	CNAET0
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/29/2024
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 surgeon reported during intraocular lens (iol) implant procedure, surgeon could see an oil like film on the surface of iols.When surgeon touched the iol after implantation with a hook or hydro needle, only the touched area seems to be peeled off.The surgeon commented that as for the iol surface, it may look like an indentation made at the time of implantation and may look like the reflection of a ceiling light.The surgery was performed and completed without product replacement.Additional information has been requested.There are seven medical device reports associated with this complaint.This report is 5 of 7.
Additional Manufacturer Narrative
Additional information was provided in h.11.Only photo & video were returned.Photo review: upon reviewing the appearance of these photographs and referencing the information in the initial report description, along with the complaint lot search findings indicating no other similar complaints have been reported against the associated intraocular lens (iol) lot, the exact nature of the reported findings shown in these photographs cannot be determined.Further evaluation, requiring additional supporting information and/or material, is needed to assess the relevance of these photographs to the complaint investigation.Video review: received video shows iol explantation.The video then shows an iol implantation in the same eye.When implanted, the iol is manipulated in what appears to be an attempt to demonstrate the issue.Under certain lighting conditions the iol optic appears cloudy.Complaints have been received reporting a potential presence of polychromatic sheen.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC 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: 21057382
• Report Number: 9612169-2025-00014
• Device Sequence Number: 8153557
• Product Code: POE
• UDI-Device Identifier: 00380652406345
• UDI-Public: (01)00380652406345(17)270225(11)230227(10)25602301
• 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): 03/07/2025

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: CNAET0
• Device Catalogue Number: CNAET0.220
• Device Lot Number: 25602301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/07/2025
• Date Device Manufactured: 02/27/2023
• 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: UNSPECIFIED HOOK OR HYDRO NEEDLE
• Patient Sex: Unknown