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

Model Number	SY60WF
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during cataract surgery with an intraocular lens (iol) implantation procedure it was observed that the injector plunger could not advance the folded iol through the narrow section of the cartridge.This led to a cartridge crack and subsequent damage to the iol.On the same day the patient was implanted with another identical iol.Additional information was received stating that, the surgeon assumes that something was wrong with the lens, previously there were no issues.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
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 was observed on the returned photo.Two photos were provided.The first photo was of the carton endcap with the label information.The second photo showed a company cartridge on top of the carton.The view was from the bottom.Viscoelastic was observed in the cartridge.The nozzle appears to be cracked.The magnification of the photo does not allow for a determination of further damage.A yellow lens model was visible in the nozzle tip.The lens appeared to be damage.The observed damage may indicate a plunger override occurred.Physical evaluation of the sample would be necessary to determine a root cause.The root cause for the reported complaint could not be determined.No sample was returned for analysis.Only photo was returned.The product was subject to handling; based on our observation of the returned photo, the lens was observed inside the company cartridge tip.We are unable to confirm the lens position in the cartridge for advancement.The origin of the observed damage cannot be confirmed based on the returned photo alone and without evaluating the physical product.In addition to this, all intraocular lens (iol) undergo 100% cosmetic inspection in accordance with approved manufacturing procedures.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 23922799
• Report Number: 9612169-2025-02632
• Device Sequence Number: 9029666
• Product Code: HQL
• UDI-Device Identifier: 00380652251426
• UDI-Public: (01)00380652251426(17)280707(11)240709(10)25887728
• Combination Product (Y/N): N
• Initial Reporter Country: BO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: SY60WF
• Device Lot Number: 25887728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 07/09/2024
• 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 OPHTHALMIC VISCOSURGICAL DEVICE.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Patient Sex: Unknown