MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Macular Edema (1822); Vitreous Floaters (1866); Blurred Vision (2137); Visual Disturbances (2140)
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 consumer reported that following an intraocular lens (iol) implant procedure in the left eye.The patient experienced awesome vision the day after the surgery; however, vision continuously went downhill and four weeks later floaters and film were developed.A laser procedure was performed with no change in vision.A vitrectomy was also performed by a different surgeon to remove fluid, floaters, and film.After the vitrectomy, the patient reported clearer in the left eye, but no change in vision.The patient question was whether the cataract surgeon might have implanted the wrong prescription lenses or even swapped the lenses between the eyes.Patient cannot drive and being in the car at night was intolerable due to the brightness.Even brightness during the day was an issue along with needing glasses to see.The patient would end up having to wear glasses for all vision, near and far and the glare was intolerable.Additional information has been requested and received stating that the patient was concerned about the poor vision after surgery.When the floaties, black dots and film happened, patient contacted right away and made an appointment.Surgeon was going to do a laser procedure and then changed mind, at first, as surgeon said patient had macular edema in both eyes.Finally, he thought it was clear enough to go ahead and performed the laser procedures a week apart from each other.Surgeon stated patient always have had macular edema.But patient reported that it was not true, patient had to took antibiotic, believed 3 days before surgery and then a week after for each eye, along with corticosteroid 4 times a day.Patient was also given an ointment to use for the first few days, but did not have that prescription available.Symptoms for the need of cataract surgery started probably 2 months after the vitrectomy was performed which surgeon had instructed patient to seek out a surgeon for cataract surgery as it was an automatic result that happens with a vitrectomy.Both eyes were affected.Symptoms, concerns and issues are poor vision in both eyes, even after laser procedures.Patient had floaties, black dots and a film in the left eye that was removed with the vitreous fluid.The eye vision was clearer, not as milky, but vision was not improved.Surgeon recommended to follow up with an optometrist in 3 plus months, giving patient left eye time to heal.Patient had listed the different procedures surgeon performed, even mentioned giving patient contacts to wear to improve vision.This was not what patient had planned for.With the diagnosis of macular edema surgeon put patient back on corticosteroid to decrease the swelling, which never improved anything, but finally surgeon agreed to do the laser procedure as a last resort with absolutely no change in vision.Patient had been in touch with surgeon regarding issues.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
Additional information was provided in b.6., d.3., d.10.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed, and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.Each lens is subjected to a 100 percent assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The reporter was the patient.The reporter indicated the initial vision with the left eye was great but gradually diminished over time.The surgeon did not provide any information related to the cause of the reported events.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21373678
• Report Number: 1119421-2025-00370
• Device Sequence Number: 3849317
• Product Code: MJP
• UDI-Device Identifier: 00380652458399
• UDI-Public: (01)00380652458399(17)260507(11)220509(10)15401639
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2025

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: 05/07/2026
• Device Model Number: CCWTT5
• Device Catalogue Number: CCWTT5.175
• Device Lot Number: 15401639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/14/2025; 04/01/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/14/2025; 04/28/2025
• Date Device Manufactured: 05/09/2022
• 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: AMVISC OVD
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown