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)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
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
A healthcare professional reported following an intraocular lens (iol) implant procedure, the patient experienced glare and decrease in visual acuity.Surgery was performed with incorrect diopter due to patient¿s irregular cornea and dry eye syndrome.The lens was explanted and replaced with another lens in a secondary procedure.The patient¿s visual acuity was improved after lens exchange.Additional information was requested.
Additional Manufacturer Narrative
Correction information was provided in d.4.Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis and the reported complaint could not be confirmed.Iol returned wrapped in surgical material.Solution is dried on the iol.Both haptics are intact.The optic is cracked or fractured and scratched or marked rejectable with loose fibers and particulate.Incorrect diopter surgery was performed due to patients irregular cornea and dry eye syndrome.Iol exchange decision was made.Iol exchange surgery was performed.Patients visual acuity was improved after exchange.The root cause for the reported complaint appears to be a coincidental event that was unrelated to the product.According to the information in the file, the initial choice of diopter wasn¿t suitable for the patients eye condition.The irregular cornea and dry eye syndrome likely made it difficult to select the correct diopter initially.This led to the need for an iol exchange to improve the patients vision.Patients visual acuity was improved after exchange to a different diopter.Based on this information, the product did not cause or contribute to the event.Based on the results from the product history record, the products met release criteria.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: 20261051
• Report Number: 9612169-2024-00914
• Device Sequence Number: 8704753
• Product Code: MFK
• UDI-Device Identifier: 00380652408264
• UDI-Public: (01)00380652408264(17)280211(11)240213(10)25794897(21)25794897034
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: CNWTT0.270
• Device Lot Number: 25794897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/11/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male