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	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, lens was explanted in secondary procedure due to patient experienced vision not clear, haze/film over vision.Clinical reason was reported to be generalized dysphotopsia.The iol was replaced with other company lens approximately four months after initial procedure.Additional information was requested and received stating there was no patient harm.
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).
Additional Manufacturer Narrative
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: 20256257
• Report Number: 9612169-2024-00913
• Device Sequence Number: 20704280
• Product Code: MFK
• UDI-Device Identifier: 00380652408011
• UDI-Public: (01)00380652408011(17)261216(11)221218(10)25567446(21)25567446141
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: CNWTT0.145
• Device Lot Number: 25567446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/17/2024
• Date Device Manufactured: 12/18/2022
• 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.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 MO
• Patient Sex: Female