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

Model Number	CCWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported following an intraocular lens (iol) implant procedure, post 8 months of surgery the patient experienced shaking in vision and it does not happen when a low light situations.Reading is very difficult.Additional information has been received and stated that the patient also had negative disphotopsia in the periphery of my left eye and slight starbursts at night when driving.The image appeared to be shake or go badly out of focus, it lasts for a split second.It is very significant when reading and under bright lights.If i focus on an item and move the item while following it, the shaking does not occur.In low light situations, it is almost non-existent.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed, and the documentation indicated, the product met release criteria.Information was provided that a qualified cartridge and handpiece were used.Two viscoelastic were indicated.Both are qualified for use with this qualified combination.The product investigation could not identify a root cause for the reported complaint.The product remains implanted.Each lens is subjected to a 100% assessment of the power (sphere and cylinder) and optical resolution, during the manufacturing process in order to determine acceptability, per the lens model and diopter.Information was provided, that the company model toric intraocular lens (iol) was placed in my left eye on (b)(6) 2023.Currently, have not had a new lens placed in my right eye.The consumer reported, that at the six month follow up, the shaking was not present.The consumer believes perhaps, due to eyes being dilates.Per the consumer, when the dilation wore off, the shaking came back.The consumer indicated, that the doctor suggested to do a lens exchange, but the consumer reported vision was excellent for clarity and depth of focus.So, the consumer stated, being hesitant, that a new lens may produce the same reported shaking effect.The consumer, has also stated, that they may seek a second opinion.If additional info is received, we will reopen and update.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; 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: 19447482
• Report Number: 1119421-2024-01048
• Device Sequence Number: 3239912
• Product Code: MJP
• UDI-Device Identifier: 00380652457439
• UDI-Public: 00380652457439
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: 09/24/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.225
• Device Lot Number: 15486793
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/12/2024
• Date Device Manufactured: 09/26/2022
• 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 OVD; MONARCH III IOL, INJECTOR; MONARCH III IOL,CARTRIDGE D; PROVISC OVD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female