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

Model Number	CNW0T3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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 non-healthcare professional reported that during an intraocular lens (iol) implant procedure, it was noted that the upper haptic broke off and remained in the cartridge.Therefore, the iol could not be implanted.There was no impact on patient.The surgery was completed with another unspecified lens.Additional information has been requested.
Event or Problem Description
Additional information has been requested, received and stated the iol was implanted in the socket and was explanted due to a damaged haptic during initial procedure.
Additional Manufacturer Narrative
Additional information provided in b.5., d.10.And h.6.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.The product was not returned for analysis.The reported complaint was observed on the returned photo.Provided photo shows iol carton and open lens case with sn (b)(6) and a cartridge.The lens is in the lens case base well and appears to be damaged.The haptics appear to be damaged/broken or folded over the optic; this cannot be confirmed due to the quality of the photo.The reporter stated the use of "pe-ha-visco 2% lot ya198a", this is not qualified for use with the associated iol model.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 viscoelastic.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: 22828361
• Report Number: 9612169-2025-01666
• Device Sequence Number: 13095513
• Product Code: MJP
• UDI-Device Identifier: 00380652409742
• UDI-Public: (01)00380652409742(17)280222(11)240224(10)25804662
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2025

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 Model Number: CNW0T3
• Device Lot Number: 25804662
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 10/17/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/19/2025; 11/10/2025
• Date Device Manufactured: 02/24/2024
• 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.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PE-HA-VISCO 2% LOT YA198A.; UNSPECIFIED CARTRIDGE.
• Patient Sex: Unknown