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

Model Number	CNW0T4
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2025
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 facility representative reported that during surgery, an attempt was made to implant the lens, but it was defective / torn.There was no harm to the patient, and a backup unit was used.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.The product was returned for analysis and damage to the iol was observed.Lens received broken in three pieces: two pieces stuck to the lens case lid, one piece loose in the carton.Solution is dried on the iol pieces.One haptic is broken and not returned, the other haptic is deformed.The optic is broken and scratched/marked-rejectable.The same photo was attached to qs 2971658 and qs 2971716.No clarification was received on which of the two files the photo is related to.Provided photo shows a lens in an opened lens case.The lens is split-cut dividing the lens in two.One segment of the iol is located in the lens case base well, the other segment of the iol is sitting on the lens case lid.One haptic appears to be broken and not present.We are unable to determine the root cause for the reported complaint "an attempt was made to implant it, but it was defective / torn".The lens was returned cut in segments.The observed damage is consistent with lens having been explanted.Solution is dried on the lens which shows evidence of possible handling by the customer.The reported complaint is lacking in relevant information such as associated products used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the iol contributed to the event.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damaged lens would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.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: 23790729
• Report Number: 9612169-2025-02500
• Device Sequence Number: 16065560
• Product Code: MJP
• UDI-Device Identifier: 00380652410168
• UDI-Public: (01)00380652410168(17)281006(11)241008(10)25921158
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: Other
• Device Model Number: CNW0T4
• Device Lot Number: 25921158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown