MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Codes	Scratched Material (3020); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Eye Injury (1845); Insufficient Information (4580)
Date of Event	05/28/2025
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during the intraocular lens implant procedure, the lens entered the eye with a piece of the haptic broken off and completely scratched.A quadrant was broken off, and the remaining lens was removed from the eye.Three stitches of 10.0 nylon were administered.The surgery was not completed.Additional information has been requested.
Event or Problem Description
Additional information has been received that the surgeon widened the incision to 3.2 mm to remove the lens during initial procedure.The company model replacement lens was used to complete the surgery.
Additional Manufacturer Narrative
Corrected information provided in b.5.And h.6.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.The complainant indicates the use of company handpiece which is not qualified for use with the associated iol model.The product investigation could not identify the root cause for the reported complaint.The customer indicates the use of a non-qualified handpiece, this may have contributed to the complaint.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) 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.In addition to this, ifu (instructions for use) instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.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.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 EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 22296709
• Report Number: 9612169-2025-01256
• Device Sequence Number: 8875479
• Product Code: POE
• UDI-Device Identifier: 00380652405287
• UDI-Public: (01)00380652405287(17)290107(11)250109(10)25980952
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

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: CNWET0
• Device Lot Number: 25980952
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 08/15/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/11/2025; 09/09/2025
• Date Device Manufactured: 01/09/2025
• 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 INJECTOR; MONARCH III CARTRIDGE D; VISCOAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown