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

Model Number	CCWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that following the intraocular lens (iol) implant procedure, the patient experienced glare and halos.The iol was exchanged in a secondary procedure.Clinical reason for explant is dysphotopsia.Additional information has been requested.
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).
Event or Problem Description
Additional information received and stated that, company lens was replaced with another model of company lens indicating the correct lens was not implanted initially.There is no reported defect or fault with the iol.
Additional Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.No further reports is required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING 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: 17085601
• Report Number: 9612169-2023-00434
• Device Sequence Number: 19534386
• Product Code: MJP
• UDI-Device Identifier: 00380652457231
• UDI-Public: 00380652457231
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2025
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.125
• Device Lot Number: 25289823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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 INJECTOR; CLAREON TORIC UV ABSORBING IOL; MONARCH CARTRIDGE D; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female