MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. 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	Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that after intraocular lens (iol) implantation on (b)(6) 2024, the patient had visual acuity complaints in her right eye.Patients follow-up visit notes are give below: (b)(6) 2024: very blurry vision.(b)(6) 2024: light sensitivity and vision was still blurry.She had corneal edema.(b)(6) 2024: light sensitivity, blurry vision, halos around lights.She was able to read with +2.00 otc reading glass.She had dry eye syndrome secondary to tear deficiencies.(b)(6) 2024: vision was unchanged, still very blurry.Current glasses had plano lens in right eye.Patient was not sure if dryness was still elevated.She had light sensitivity.Halos had increased at night, she had to close her right eye when passing another vehicle.Vision was not sharp and colors were duller.She had dry eye syndrome secondary to tear deficiencies.(b)(6) 2024: still had blurry vision, like a haze over right eye at all distances.Still had halos.She had dry eye syndrome secondary to tear deficiencies.An explant has been planned.
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
Additional information has been received stating as per surgeon's opinion not product related problem, the patient was not happy about having halos around lights.The iol was exchanged for non company lens 21.5 diopter model 1 months 25 days following the initial implant procedure with no patient harm.
Additional Manufacturer Narrative
Correction information was provided in d.4.Additional information was provided in b.2., b.5., b.6., d.6.B., d.10., e.4., h.3., h.6., and h.11.The instructions for use (ifu) states that some visual effects may be expected due to the superposition of focused and unfocused multiple images.These may include some perception of halos, radial lines around point sources of light (starbursts) under night-time conditions, or glare, as well as other visual symptoms.As with other multifocal iols, there is a possibility that visual symptoms may be significant enough that the patient will request explant of the multifocal iol.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 20310689
• Report Number: 9612169-2024-00953
• Device Sequence Number: 7726833
• Product Code: MFK
• UDI-Device Identifier: 00380652408172
• UDI-Public: (01)00380652408172(17)270404(11)230406(10)25630519(21)25630519159
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: CNWTT0.225
• Device Lot Number: 25630519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/27/2024
• Date Device Manufactured: 04/06/2023
• 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: BESIVANCE.; CLOBETASOL PROP.; DUOVISC OVD.; KETOROLAC.; MC PHERSON FORCEPS.; MONARCH II LOADING FORCEPS.; MOXIFLOXACIN.; MURO 128 TID.; ORA SYSTEM WITH VERIFEYE MESSAGING.; OXYBUTYNIN CHLORIDE.; PREDNISOLONE ACETATE.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.; SYSTANE COMPLETE LUBRICANT EYE DROPS.; ULTRATA FORCEPS.; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.; ZOLPIDEM.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female