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

Model Number	CCW0T3
Medical Device Problem Codes	Product Quality Problem (1506); Dent in Material (2526)
Health Effect - Clinical Code	Insufficient Information (4580)
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 non-healthcare professional reported that during an intraocular lens implantation procedure, the intraocular lens edges were too sharp and that the surgery ended up requiring a vitrectomy.The surgery was completed with another lens.Additional information has been requested.
Additional Manufacturer Narrative
Corrected information provided in h.6., and h.11.Correction: on initial mdr the product code of a040602 was an error.It should have been a0201 on the original mdr.On initial mdr the imdrf health impact code of f1905 was missed.It should have been submitted in the initial mdr.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC 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: 21460768
• Report Number: 1119421-2025-00526
• Device Sequence Number: 7680355
• Product Code: MJP
• UDI-Device Identifier: 00380652431682
• UDI-Public: (01)00380652431682(17)270108(11)230110(10)15570750
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCW0T3
• Device Lot Number: 15570750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/17/2025
• Date Device Manufactured: 01/10/2023
• 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 Sex: Unknown