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

Model Number	CNWET4
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Eye Injury (1845); Visual Impairment (2138)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that the patient myopic post uveitis/post vitrectomy due to retinal detachment in the right eye (od), had discussed beforehand that if the psc did not come off automatically, would leave it in place and laser it later, as they were unsure of the integrity of the capsule.During surgery back up intraocular lens (iol) did not load properly and a crack was visible after implantation and no other back up lens so the left the lens implanted.The patient has poor vision due to his posterior capsule opacification (pco), so physician not sure how much the crack bothers him yet.His other eye does not need surgery so, hesitant to do an intraocular lens (iol) exchange in this post vitrectomy eye, but a yag (yttrium aluminum garnet) in a month will make an iol exchange even harder and prevent a lens from being re-implanted together.Additional information received and it states that the first lens did not go in properly was stuck halfway in the wound and had used usual 2.2mm so, enlarged the wound to be safe and noticed with that lens that it felt particularly stiff removed during initial procedure.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Corrected information has been provided in b5.Additional information has been provided in h.3., h.6., and h.11.The product was not returned for analysis.Only photo was returned.The reported complaint is observed on the returned photo.The returned photo shows implanted intraocular lens (iol).There is a dark mark/line visible on the iol optic.We are unable to determine the root cause for the reported complaint 2nd lens did not load, had large crack, removed, poor vision.The product was not returned for evaluation.Only photo was returned.Based on our observation of the attached photo, there is a dark mark/line visible on the iol optic.The product was subject to handling and the reported damage was highlighted post implantation.In addition to this, all iols are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.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 received and it states that the first lens was did not enter the eye properly was stuck halfway in the wound and had used usual 2.2mm, enlarged the wound to be safe and noticed with that lens that it felt particularly stiff, second lens had a did not load properly and a crack was visible after implantation, removed during initial procedure, poor vision and third lens had small crack at haptic junction and it remains implanted.

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION 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: 21135855
• Report Number: 9612169-2025-00083
• Device Sequence Number: 15372774
• Product Code: MJP
• UDI-Device Identifier: 00380652466660
• UDI-Public: (01)00380652466660(17)270406(11)230408(10)25619896
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: CNWET4
• Device Catalogue Number: CNWET4.135
• Device Lot Number: 25619896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 04/08/2025
• Date Device Manufactured: 04/08/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Unknown