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	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	09/18/2024
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 facility representative reported following an intraocular lens (iol) implant procedure, the patient experienced distortion in his vision and the patient vision after the surgery is worse than before the surgery.The patient underwent yag laser capsulectomy.Additional information has been requested.
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 product remains implanted.Each lens is subjected to a 100percentage 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.It is unknown if the lens is at the correct axis.Per the instructions for use (ifu) misalignment of the axis of the lens versus the intended axis of placement may compromise its astigmatic correction.Such misalignment can result from inaccurate keratometry or marking of the cornea, inaccurate placement of the toric iol axis during surgery, an unanticipated surgically induced change in the cornea, or physical rotation of the toric iol after implantation.In order to minimize this effect, the surgeon should be careful to ensure that preoperative keratometry and biometry is accurate and that the iol is properly oriented prior to the end of surgery.The ifu also instructs carefully remove all viscoelastic from both the anterior and posterior sides of the lens.Residual viscoelastic may cause complications including lens rotation resulting in misalignment of the company model toric trifocal uv absorbing iol with the intended axis of placement.The ifu instructs that rotation of the company model iols toric trifocal uv absorbing iol away from its intended axis can reduce the astigmatic correction.Misalignment greater than 30 degrees may increase postoperative refractive cylinder.If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.The reporting health care provider indicated they were not the implanting surgeon.The reporter feels the issue is related to higher order aberrations.Requested file be sent to global quality customer affairs.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; 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: 20618439
• Report Number: 1119421-2024-02158
• Device Sequence Number: 18030613
• Product Code: MJP
• UDI-Device Identifier: 00380652457392
• UDI-Public: (01)00380652457392(17)260523(11)220525(10)15409711
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: 05/23/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.205
• Device Lot Number: 15409711
• Was Device Available for Evaluation?: No
• 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: 12/26/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 01/20/2025
• Date Device Manufactured: 05/25/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male