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

Model Number	CNWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that after intraocular lens (iol) implant procedure, after two weeks of post operation the patient experienced intolerable glare and halos by the company lens so, the patient was not able to drive during the day or at night.Even streetlights had rings around them.Due to the surgeries, the patient also had induced astigmatism in this eye.Hence the lens was explanted and replaced with another lens with different model in a secondary procedure.Patient also underwent yag (yttrium-aluminum-garnet) laser after the exchange and need a refractive touch up with prk (photorefractive keratectomy).In the surgeon's opinion, the prognosis of the patient was good.There was no further impact to the patient.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).H10 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
• 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: 22739408
• Report Number: 9612169-2025-01578
• Device Sequence Number: 18468141
• Product Code: POE
• UDI-Device Identifier: 00380652405102
• UDI-Public: (01)00380652405102(17)271119(11)231121(10)25751453
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.130
• Device Lot Number: 25751453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/07/2025
• Date Device Manufactured: 11/21/2023
• 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: CLAREON PANOPTIX TRIFOCAL IOL; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; NON-TOOTHED STRAIGHT FORCEPS; ORA VERIFEYE MESSAGING, CART; PROVISC
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female