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

Model Number	CNWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Hyporesponsive to stimuli (2683); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported following an intraocular lens (iol) implant procedure, patient stated he had surgery 4-5 weeks ago and had terrible side effects like glare during day, headaches, nausea and loss of contrast sensitivity.Patient stated his vision was 20/20.Did not have cataracts did a clear lens exchange.He had some corneal issues after surgery and had to use muro 128.This was resolved.
Additional Manufacturer Narrative
Additional information was provided in h.3, h.6 and h.10.The product was not returned for analysis.The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.There has been one another complaint reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
D.3.Product manufacturing site updated due to receipt of product serial number.G.9.Manufacturer report number corrected and reported under 9612169-2023-00105.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating issues were still present, very bright large starburst, ray beams from 7-2 o'clock position, and huge halos, long range distance not as good anymore and a graininess at night.Patient was 20/20 but there were a lot of other issues as described.It had been going on as of now 4 months.Surgeon said everything was perfect with the lens.

• 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 WV 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork WV 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15842856
• Report Number: 1119421-2022-02452
• Device Sequence Number: 5982849
• Product Code: MJP
• UDI-Device Identifier: 00380652468572
• UDI-Public: 00380652468572
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2023
• 2 Devices were Involved in the Event: 1 2

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: 01/12/2025
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.220
• Device Lot Number: 25253491
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 01/11/2023; 02/19/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 02/07/2023; 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male