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

Model Number	CNWET6
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
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.Provided two photos show an implanted iol on a screen.There appears to be a dark line/mark/crack in the optic.Another shorter line/mark is also visible over the optic.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during cataract surgery with intraocular lens (iol) implantation, the implanted lens was found to have a crack in the optic.The defect was detected during the surgery, however the surgery was completed by implanting the same lens.The patient was not hospitalized.The lens was scheduled to be explanted on (b)(6) 2025 (future date at the time of the report), with a replacement lens already ordered, in accordance with the clinic¿s protocol.Additional information has been received and confirmed that the iol had been explanted and discarded as per the clinic¿s protocol on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information provided in h.11.The product was not returned for analysis.Only photos were returned and the reported complaint was observed on the photos.Provided two photos show an implanted iol on a screen.There appears to be a dark, long line/mark in the optic.Another shorter line/mark is also visible over the optic close to the gusset area.Based on our observation of the attached photo, there appears to be a dark, long line/mark in the optic, another shorter line/mark is also visible over the optic close to the gusset area.The origin of the observed lines/marks cannot be confirmed based on the returned photo alone and without the evaluation of the physical product.A crack can occur if the iol is placed incorrectly in the delivery device and/or if the correct dwell time is not adhered to as this can result in stress on the iol as it travels through the delivery device/cartridge resulting in a crack/fracture of the optic.The cartridge instructions for use (ifu) instructs: the lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.It also instructs that prior to loading the iol, the cartridge must be used at operating room temperature of between 18°c and 23°c.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The iol ifu instructs: during lens loading and insertion, do not allow the company iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.In addition to this, company foldable iols are qualified for use with an company qualified delivery system and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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).

• 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: 23791399
• Report Number: 9612169-2025-02503
• Device Sequence Number: 14839387
• Product Code: MJP
• UDI-Device Identifier: 00380652467605
• UDI-Public: (01)00380652467605(17)271113(11)231115(10)25751499
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: CNWET6
• Device Lot Number: 25751499
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/09/2026
• Date Device Manufactured: 11/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown