MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWTT4
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Dizziness (2194)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non health care professional reported that after implantation of intraocular lens, the patient had blurry vision, dizziness.The lens was explanted in a secondary procedure and replaced with an another lens of same model but different diopter.The clinical reason for explant was refractive surprise and lens off axis.Additional information was received stating that there was a refractive surprise after the initial implant.The patient had a large cataract which made the measurements difficult/not accurate.
Additional Manufacturer Narrative
A sample device 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).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 17126743
• Report Number: 9612169-2023-00452
• Device Sequence Number: 17754354
• Product Code: MJP
• UDI-Device Identifier: 00380652468893
• UDI-Public: 00380652468893
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2025
• Device Model Number: CNWTT4
• Device Catalogue Number: CNWTT4.115
• Device Lot Number: 25281177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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 IOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown