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 Codes	Blurred Vision (2137); Insufficient Information (4580)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis; the lens remains implanted.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
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 this iol finding clearly visible under a microscope but not so much on video.The surgery was performed and completed without product replacement.Additional information has been requested.There are ten medical device reports associated with this report.This is 5 of 10.
Event or Problem Description
Additional information has been requested and received stating patient was experiencing poor vision, also reported there might be possible patient harm.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo and video was returned.The reporter stated: "it seems that the surgeon has not been able to keep checking the condition or iol(intraocular lens), so it is unclear whether the finding is continuing or have disappeared".Photos & video review: photo review: 10 photos received.The optic appears to have a clouded appearance in the photos under different light settings.Video review: the video shows iol implantation.As the iol enters the eye and begins to unfold it is manipulated into position with a surgical tool.During this manipulation a slight cloudiness can be seen on the optic under certain light conditions/light reflections.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 21091263
• Report Number: 9612169-2025-00050
• Device Sequence Number: 21066495
• Product Code: POE
• UDI-Device Identifier: 00380652406277
• UDI-Public: (01)00380652406277(17)270217(11)230219(10)25602284
• 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): 02/15/2025

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: CNAET0.185
• Device Lot Number: 25602284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/15/2025
• Date Device Manufactured: 02/19/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Female