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

Model Number	CNW0T9
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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.Provided photo shows an implanted iol.There appear to be white marks/lines on the optic.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.
Event or Problem Description
A physician reported that during cataract surgery with an intraocular lens (iol) implant procedure, there was a mark on the implant.There was no issue occurred during folding.Additional information has been requested but no information is available at the time of this report.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.The reported complaint appears to be observed on the returned photo.Provided photo shows an implanted intraocular lens (iol).There appear to be white marks/lines on the optic.Based on our observation of the attached photo, there appears to be marks/lines on the optic.The origin of the observed marks/lines cannot be confirmed based on the returned photo alone and without evaluating the physical product.The product was subject to handling, and the reported damage was highlighted post implantation.The reporter stated that no defects or abnormalities were identified prior implantation.Additional records were opened for company cartridge and company handpiece.In addition to this, all iols undergo 100 percent 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.
Event or Problem Description
Additional information was requested and it was reported that prior to implantation, the intraocular lens had been inspected in accordance with standard procedures, with no defects or abnormalities identified at that stage.Regarding the presence of a potential scratch and its functional impact, postoperative follow-up indicated no significant visual discomfort, and the best-corrected visual acuity remained stable at 8/10.The possible scratch was reported not to be located in the visual axis, or if present, it did not result in any noticeable functional impairment.Based on the available findings, no confirmed defect of the implant was identified.A malfunction of the injector could not be entirely ruled out; however, no clinical evidence supported this hypothesis.As a precautionary measure, the injector in question was considered for withdrawal from stock.The postoperative course was reported as favorable, with stable condition, unchanged oct (optical coherence tomography) findings, and normal intraocular pressure.Routine follow-up was to continue as per standard protocol.In view of the absence of functional complaints and clinical stability, no explantation was planned.As per reporter no further information was expected for this report.

• Brand Name: CLAREON TORIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 24927070
• Report Number: 9612169-2026-00891
• Device Sequence Number: 5180816
• Product Code: MJP
• UDI-Device Identifier: 00380652412766
• UDI-Public: (01)00380652412766(17)280210(11)240212(10)25794597
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: CNW0T9
• Device Lot Number: 25794597
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/05/2026
• Date Device Manufactured: 02/12/2024
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• Patient Age: 78 YR
• Patient Sex: Female