MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON 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	Dry Eye(s) (1814); Blurred Vision (2137); Halo (2227); Skin Disorders (4543)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the right eye (od) biggest issue was halos around lights at night was severe and have not improved and was probably somewhat worsen right after surgery.The patient cannot drive at night at all and had completely stopped driving at night because of the halos.The patient tried eye drops but neither one helped at all and seemed to make vision less clear overall and even sees halos around lights during the day but not as debilitating as the night.The patient also experienced dry eye syndrome and hypertrophic disorder of the skin.As per surgeon there were posterior capsule (pc) wrinkles and there was no posterior capsular opacification, and it was highly doubtful any posterior capsular wrinkly would be the cause of this type of severe halo.Yag posterior capsular therefore mostly likely would not help that patient so surgeon, wished to proceed with intraocular lens (iol) exchange with non-company lens but was unsure of what power.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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
Additional information has been received stating the iol was exchanged for non-company lens 6 months 6 days following the initial implant procedure.
Additional Manufacturer Narrative
Additional information was provided in b.5., d.5., d.6.B., and h.6.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 RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20372529
• Report Number: 1119421-2024-01956
• Device Sequence Number: 14401827
• Product Code: MFK
• UDI-Device Identifier: 00380652408103
• UDI-Public: (01)00380652408103(17)251211(11)211213(10)15320743
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 12/11/2025
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.190
• Device Lot Number: 15320743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/09/2024
• Date Device Manufactured: 12/13/2021
• 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; Other
• Patient Age: 69 YR
• Patient Sex: Female