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

Model Number	CNW0T7
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported that during the intraocular lens (iol) implantation surgery, the haptic was broken during unfolding of the lens while the lens was already in the eye.Hence the lens was cut and removed from the patient's eye and replaced with another lens during the same procedure.Additional information was received stating that the wound was enlarged and additional stiches was required.
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
The product was not returned for analysis.Only photo was returned.The reported complaint was observed on the returned photo.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Provided photo shows an implanted iol.One haptic appears to be broken and is over the optic.The complainant indicates the use of monarch iii d cartridge, which is not qualified for use with the associated iol model and diopter.Based on our observation of the attached photo, the iol is implanted, one haptic appears to be broken and is over the optic.Based on the information provided by the customer, the most likely root cause is failure to follow ifu, as the surgeon states the use of non-qualified cartridge.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis, and the reported complaint was observed.An approximately 50% of the intra ocular lens (iol) was received in the lens case.One haptic is broken/torn and not returned.The other haptic and the remaining iol optic are not returned.Solution is dried on the returned segment.Provided photo shows an implanted iol.One haptic appears to be broken and is over the optic.The complainant indicates the use of company cartridge, which is not qualified for use with the associated iol model and diopter.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow instructions for use (ifu), as the surgeon states the use of non-qualified cartridge.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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 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: 24019794
• Report Number: 9612169-2026-00084
• Device Sequence Number: 10550609
• Product Code: MJP
• UDI-Device Identifier: 00380652411653
• UDI-Public: (01)00380652411653(17)290704(11)250706(10)26061999
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 03/31/2026

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: CNW0T7
• Device Lot Number: 26061999
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/09/2026; 03/06/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/05/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2025
• 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: CLAREON MONARCH IV INJECTOR.; MONARCH III CARTRIDGE D.; PROVISC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown