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 Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Prolapse (2475)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint could not be determined.No sample was returned for analysis.The file states that the doctor initially injected part of the lens, then removed the injector to insert the iris.After treating the iris and high eye pressure with viscoelastic, the lens was manipulated in three attempts.Eventually, the eye stabilized slightly, but the lens came out with a broken optic.The duration the lens remained folded in delivery system before final implantation is unknown.The instructions for use (ifu) instructs during lens loading and insertion, do not allow the company intraocular lens (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.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A pharmacist reported that during surgery doctor performed a phaco on the patient.He said that the surgery would be complex and that the patient takes medication for his prostate, which would make the procedure more difficult because of the iris.The surgery went well.When the doctor proceeded to inject the lens, the iris came out.The doctor had already injected a little of the lens, he took out the injector and inserted the iris.He placed unspecified viscoelastic and treated the iris and the high pressure in the eye again.It could not be repositioned.Three attempts were made in which the lens was manipulated.Finally, the eye stabilized a little better.The doctor injects the lens, which comes out with a broken optic.The lens was not removed because it remains stable in the eye.In addition, it would be more risky for the patient due to the conditions to change it.Additional information has been received and it states that the intraocular pressure (iop) was increased for the patient.

• 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: 21678938
• Report Number: 9612169-2025-00460
• Device Sequence Number: 7693284
• Product Code: POE
• UDI-Device Identifier: 00380652405263
• UDI-Public: (01)00380652405263(17)280522(11)240524(10)25861085
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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 Catalogue Number: CNWET0.210
• Device Lot Number: 25861085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/24/2025
• Date Device Manufactured: 05/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION VISION SYSTEM; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown