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

Model Number	CC60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
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 (iol) implant procedure, part of the haptic missing.This was noticed during loading and there was no patient contact.The procedure was completed using another iol.Additional information has been requested.
Event or Problem Description
Additional information has been requested and received stating that tech recognized the haptic was missing before starting to fold the lens.
Additional Manufacturer Narrative
The product was not returned.Two identical photos were provided of a clear lens positioned incorrectly in the lens case.The optic appears to be pressed against two posts of the lens case, and one haptic appears to be broken near the gusset area.The presence of viscoelastic cannot be confirmed from the photo.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The account indicated the use of qualified associated products; however, the damage was reported as noticed before folding.Based on our observation of the attached photos, the haptic is broken.The account indicated the product was not available to evaluate.The presence of clinical solution on the lens cannot be determined.It is difficult to make a determination of handling / damage without evaluation of the physical sample.A final root cause cannot be determined based on available information.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 24189980
• Report Number: 1119421-2026-00178
• Device Sequence Number: 8065099
• Product Code: HQL
• UDI-Device Identifier: 00380652396707
• UDI-Public: (01)00380652396707(17)290803(11)250805(10)16082739
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CC60WF
• Device Lot Number: 16082739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/01/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/23/2026
• Date Device Manufactured: 08/05/2025
• 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 IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC
• Patient Sex: Unknown