MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
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 streetlight's 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
The lens was returned on a small white surgical material in a sealed non-company pouch.Viscoelastic was dried on the lens.The lens was cleaned with klrp to further evaluate.The optic edge has a small torn area.The posterior optic surface has a small cracked area located between the optic center and the optic edge.The anterior optic surface has a cracked area near the outermost ring.The power and optical resolution was retested by engineering technician.The lens met specification for a company 13.5 diopter lens.A device history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Qualified associated products were used.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The returned lens was cleaned to remove the dried viscoelastic and conduct testing.The power and resolution were retested.The lens met specifications for a company 13.5 diopter lens.The company multifocal 13.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a company 13.0 diopter (1.5 extended depth of focus) lens.Due to a multifocal company 13.5 diopter lens being replaced with a company extended depth of focus lens (13.0 diopter), this suggests that the extended depth of focus replacement lens was an improved selection for this patient's vision needs.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 PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22739423
• Report Number: 1119421-2025-02179
• Device Sequence Number: 9120658
• Product Code: MFK
• UDI-Device Identifier: 00380652407991
• UDI-Public: (01)00380652407991(17)270915(11)230917(10)15585260
• 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: CNWTT0
• Device Catalogue Number: CNWTT0.135
• Device Lot Number: 15585260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• 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
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2023
• 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: 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