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

Model Number	CNWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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
A surgeon reported that following an intraocular lens (iol) implant procedure, the patient experienced vision and light blur vision was not 50 percent of corrected vision.The iol was exchanged for another unspecified model lens 2 weeks 3 days following the initial implant procedure.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
Additional information was provided in h.3.And h.11.The product was not returned for analysis.The reporter stated "incorrect diopter surgery was performed on the patient due to irregular cornea and dryness.Decision on intraocular lens (iol) exchange was made." the root cause for the reported complaint could not be determined.The reporter stated "incorrect diopter surgery was performed on the patient due to irregular cornea and dryness.Decision on iol exchange was made." this statement suggests the root cause may be related to patient condition and an iol exchange may be an improved choice for the patients vision needs.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information was provided in h.6.(on initial mdr the health impact code of f19 was submitted.It should have been f1903 on the original mdr).Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis and the reported complaint could not be confirmed.Intraocular lens (iol) returned in a small plastic bag.Solution is dried on the iol.Both haptics are intact.The optic is torn/split-cut dividing the iol in two and scratched/marked-rejectable.Additional information: the reporter stated "incorrect diopter surgery was performed on the patient due to irregular cornea and dryness.Decision on iol exchange was made patient's vision relief after exchange progression".The root cause for the reported complaint appears to be a coincidental event that was unrelated to the product as user facility reported that according to the surgeon, incorrect diopter surgery was performed on the patient due to irregular cornea and dryness; decision on iol exchange was made.Based on this information, the reported event was most likely related to patient condition and not a product issue.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 20633475
• Report Number: 9612169-2024-01132
• Device Sequence Number: 18007666
• Product Code: MFK
• UDI-Device Identifier: 00380652408080
• UDI-Public: (01)00380652408080(17)250204(11)210913(10)25263612
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2025

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: 02/04/2025
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.180
• Device Lot Number: 25263612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 03/10/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/08/2025; 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female