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

Model Number	SY60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
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 healthcare professional reported that during an intraocular lens(iol) implant procedure at the time of iol placement in the cartridge, the surgeon noticed that the iol haptic was partially detached, with a failure or crack.Therefore, surgeon was decided not to implant it and used another new iol.Additional information has been received and stated there was no patient contact.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned.The reported complaint cannot be confirmed from the returned photo.A photo was provided.The lens was shown partially inserted into a company cartridge loading area.The lens was upside down, posterior surface up instead of anterior per the diagram etched at the loading area.No haptic damage could be discerned.The damage may be on the haptic inside the cartridge.The issue may be related to the misloaded lens.We cannot confirm the reported event based on the returned photo and without the evaluation of the physical product.The reported complaint cannot be confirmed from the provided photos.A definitive determination of the reported complaint cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 21604506
• Report Number: 9612169-2025-00382
• Device Sequence Number: 15735153
• Product Code: HQL
• UDI-Device Identifier: 00380652251563
• UDI-Public: (01)00380652251563(17)260912(11)220914(10)25488484
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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 Expiration Date: 09/12/2026
• Device Model Number: SY60WF
• Device Lot Number: 25488484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 06/04/2025
• Date Device Manufactured: 09/14/2022
• 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: CLAREON MONARCH IV INJECTOR; MONARCH III CARTRIDGE D; VISCO LIGHT 2% AUROVISC
• Patient Age: 38 YR
• Patient Sex: Male