MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON 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	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Eye Pain (4467); Eye Irritation (4803)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-health care professional reported that after 1 week surgery, the patient experienced feeling of being punched in the eye and is worse as the day progression like bruised.Light is very really painful and red can see disco lights temporal.Can see the edge of the implant and very blurry.Patient also had post operative (po) laser-assisted in-situ keratomileusis (lasik)surgery and they have planned for explant.Additional information has received it states that the patient had cataract surgery and unhappy with va (visual acuity).At one week po, patient was myopic at -1.25 could not correct to clear 20/20, took that into consideration with new lens power, replaced the company lens with non company lens following the secondary implant procedure after this now she is +0.75 (aimed to correct to -1.00), no longer has distortion from lights.Additional information has received it states that the patient and clinical reason for explant mentioned as steaks of light and blurry vision.
Additional Manufacturer Narrative
The lens was returned submerged in a small vial of clear liquid.The lens was removed from the liquid and allowed to air dry completely prior to evaluation.The residue of dried viscoelastic was present on the lens.The lens was cleaned with klrp to further evaluate.A scratch was observed on the posterior optic rings.The anterior optic surface has an area of scratches and has a small gouge on the optic above the outer optic rings.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that a qualified cartridge, handpiece, and viscoelastic were used.The root cause could not be determined for the reported complaint.The explanted lens was returned.The power and optical resolution of the explanted lens was verified.The lens met specification for a company lens with 23.0 diopter.Information was provided that the multifocal company toric (1.50 cyl) 23.0 diopter (add power 2.2/3.2 diopter) was removed and replaced with a non- company toric lens 21.5 diopter lens.Due to the exchange of a multifocal toric 23.0 diopter for a multifocal toric with a difference of 1.5 diopters, this suggests that the replacement lens lower diopter may have been an improved choice for the patient vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 20514401
• Report Number: 1119421-2024-02058
• Device Sequence Number: 9232369
• Product Code: MJP
• UDI-Device Identifier: 00380652468596
• UDI-Public: (01)00380652468596(17)260712(11)220714(10)15450226
• 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
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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: 07/12/2026
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.230
• Device Lot Number: 15450226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2022
• 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: DUOVISC; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; MOXI/ KENALOG INJ; ORA SYSTEM WITH VERIFEYE MESSAGING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female