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

Model Number	CNWTT3
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced macular degeneration.Also stated that, the iol not functioning properly.They have planned for the explant of the iol.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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in a.2., a.3., b.2., b.3., b.5., b.6., d.6.B., d.10., and e.4.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that, the lens was explanted due to unable to adopt to the iol.The symptoms were resolved.
Additional Manufacturer Narrative
The root cause was determined to be a coincidental event related to patient condition as it states in the file that the reason for explant was: "level of macular degeneratin, unable to adapt to the lens".A malfunction has not been indicated or information provided that the lens was the cause of the event.Based on this information, the product did not cause/contribute to the event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient was unable to adopt to the iol.The iol was exchanged for another lens 2 months following the initial implant procedure.The clinical reason for explant mentioned as level of macular degeneration and the iol not functioning properly.The symptoms were resolved.
Additional Manufacturer Narrative
Correction information provided in b.5., and h.6 on initial mdr the evaluation method code of 2588 was an error.It should have been 4001 on the original mdr.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: 15867996
• Report Number: 9612169-2022-00653
• Device Sequence Number: 5210039
• Product Code: MJP
• UDI-Device Identifier: 00380652468497
• UDI-Public: 00380652468497
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/20/2023

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: 02/19/2025
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.180
• Device Lot Number: 25281512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 12/14/2022; 01/26/2023; 07/19/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 01/05/2023; 02/15/2023; 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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: PROVISC
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male