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

Model Number	CNWTT3
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported during intraocular lens (iol) implant procedure, when the iol was being inserted, lens optic broken/cracked/split/torn.Additional information has been requested.
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
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.Photo provided shows an implanted intraocular lens (iol).There appears to be a black mark/crack on the optic.Based on our observation of the attached photo, there appears to be a mark/crack on the optic.The origin of the observed mark/crack 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 during implantation.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).
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis, and damage was observed to the intraocular lens (iol).Lens received adhered to the outside of the iol carton, secured with a sticky clear tape.Solution is dried on the iol.The optic is torn/split-cut dividing the iol in two.Both haptics are present.Photo provided shows an implanted iol.There appears to be a black mark/crack on the optic.We are unable to determine the root cause for the reported complaint when the iol was being inserted, lens optic broken/cracked/split/torn.The iol was returned in two segments, which is consistent with lens having been explanted.The product was subject to handling, and the reported damage was highlighted post implantation.In addition to this, all iols are 100 percentage cosmetically inspected as per approved manufacturing procedures and the observed lens damage/condition would not meet our current release criteria.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 PANOPTIX TORIC TRIFOCAL HYDROPHOBIC 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: 23472201
• Report Number: 9612169-2025-02202
• Device Sequence Number: 18519020
• Product Code: MJP
• UDI-Device Identifier: 00380652468367
• UDI-Public: (01)00380652468367(17)260329(11)220331(10)25380191
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

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 Expiration Date: 03/29/2026
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.115
• Device Lot Number: 25380191
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 02/16/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/07/2026; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Patient Sex: Unknown