MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during the intraocular lens (iol) implant procedure, observed scratch at the centre of the lens when picking up the lens before inserting it into cartridge.The surgeon changed to another backup injector and backup consigned lens.There was no patient contact.Additional information has been requested.
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).
Additional Manufacturer Narrative
Additional information provided in b.2., b.5., and h.11.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a (device malfunction / incident).No further reports required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received that the scratch on lens was observed upon opening the lens.The lens was scratched when they want to insert into the cartridge.There was no patient contact.

• Brand Name: CLAREON IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23895993
• Report Number: 9612169-2025-02584
• Device Sequence Number: 4619367
• Product Code: HQL
• UDI-Device Identifier: 00380652251532
• UDI-Public: (01)00380652251532(17)280924(11)240926(10)25920455
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: SY60WF
• Device Lot Number: 25920455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2025
• Supplement Date Received by Manufacturer: 01/11/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 09/26/2024
• 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: DISCOVISC.; MONARCH III CARTRIDGE D.
• Patient Sex: Unknown