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

Model Number	CCW0T3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Only half of the lens was returned in the lens case base.Viscoelastic was dried on the lens.The lens was cut across the center.Damage was observed around the cut area that appeared to be removal damage.The small scratch reported may have been on the half of the lens not returned.Complaint and product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge was indicated with a non-qualified handpiece.It is unknown if a qualified viscoelastic was used.The root cause for the reported "small scratch" may be related to a failure to follow the instructions for use (ifu).Only half of the lens was returned.The small scratch reported may have been on the half of the lens not returned.A non-qualified handpiece was indicated.It is unknown if a qualified viscoelastic was used.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that, during intraocular lens implantation surgery, the surgeon noticed a small scratch and lens.Hence the lens was explanted and replaced with another lens during the same procedure with no further issues.There was no patient harm.

• Brand Name: CLAREON TORIC 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: 22012591
• Report Number: 1119421-2025-01377
• Device Sequence Number: 7883576
• Product Code: MJP
• UDI-Device Identifier: 00380652431835
• UDI-Public: (01)00380652431835(17)261218(11)221220(10)15557335
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 05/13/2025

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: 15557335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/13/2025
• Date Device Manufactured: 12/20/2022
• 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: MONARCH III CARTRIDGE D; PLATINUM INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female