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	Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, the patient did not had any clear distance vision but the patient can read and drive well.Additional information received and stated that, patient had significant des (dry eye syndrome) since surgery and they've given him corticosteroid and lubricant drops.The patient sought out another opinion and they said all looks good and centered.The patient will focus on dryness first, then on to another opinion for possible iol exchange in the future.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint could not be determined.No sample was returned for analysis.The product history records confirm that the product met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in d.4., b.5.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, the patient vision was better with glasses before surgery.The patient stated that, was not presented with this brochure prior to surgery.The surgeon's office has been non-responsive.The patient requested if needing to wear glasses now to watch tv clearly would be considered abnormal given the implants.

• 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: 16626145
• Report Number: 9612169-2023-00246
• Device Sequence Number: 14590342
• Product Code: MJP
• UDI-Device Identifier: 00380652468572
• UDI-Public: (01)00380652468572(17)250209(11)210918(10)25275471(21)25275471054
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: 02/09/2025
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.220
• Device Lot Number: 25275471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 01/25/2025
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2021
• 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: PF AT'S; PREDFORTE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male