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

Model Number	CNWET3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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.
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, patient experienced presbyopia which was not corrected at all and the patient cannot read without additional glasses.Astigmatism was not corrected and the vision has worsened, previously patient could work on the computer without glasses but now glasses are needed.Additional information was received and stated, on (b)(6) 2024 iol was inserted into the right eye.The next day patient noticed that right eye was not seeing well both far and near, the astigmatism was not eliminated and all objects still had a second contour.Patient could not read text from a smartphone or a book at a distance of 40-45 cm.On (b)(6) 2024, a follow up examination was conducted where patient reported all the shortcomings and were not entered into the medical record.On (b)(6) 2024 the next examination was conducted, and during the time that had passed since the first examination, there were no changes in the complaints about the right eye.During the examination, it was recorded that visual acuity was 0.6 cylindrical-1.0 axis10 = 0.9 for the right eye.Additional information was received, doctor said that these events do not pose a threat to the patients life and health and are also not clinically significant.The patient maintains high distance vision in the postoperative period.During the consultation before the operation, the patient chose to have the company intraocular lens implanted, the patient was given an explanation of the expected postoperative visual acuity and the need to use optical correction when working at close range.The patient has concomitant chronic diseases and recommended to consult related specialists.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
Correction information was provided in a3.A and b.5.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 was received and stated, patient was not complaining about the lens itself but about the final result.Her doctor stated that the implanted lens cannot meet the requirements expected of a lens.According to the patient, the requirements are not being met as her vision had deteriorated (before it was plus 5, after deterioration by several times, now it was plus 0.3 which was insufficient for glasses free vision).She had astigmatism before the surgery, but presbyopia was not corrected after the operation.

• 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: 21968307
• Report Number: 9612169-2025-00980
• Device Sequence Number: 12790156
• Product Code: MJP
• UDI-Device Identifier: 00380652466356
• UDI-Public: (01)00380652466356(17)280202(11)240204(10)25794876
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CNWET3
• Device Catalogue Number: CNWET3.160
• Device Lot Number: 25794876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/29/2025
• Date Device Manufactured: 02/04/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female