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 Code	Insufficient Information (4580)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
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 an intraocular lens (iol) implant procedure, the iol was pinched in the cutting tunnel incision and tore.The lens was removed during an initial procedure and replaced with another unspecified lens.There was not any issue the visual acuity was 1.0.Cornea was clear iol was located in capsula bag, iol was clear.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.Correction information was provided in b.5.And h.6.Correction: on initial mdr the impact code should have been f1905 instead of f24 the product was not returned for analysis.Only photo was returned, and lens damage was observed on the returned photo.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Provided photos show an iol in a lens case base.The lens is not positioned correctly in the lens case base well, the lens appears to be posterior surface up instead of anterior surface up in the iol case.One haptic appears to be broken, the other haptic is deformed.The lens optic appears to be damaged/chipped.The incision size indicated did not correlate to the recommended size for the cartridge used.Based on our observation of the attached photo, the lens is positioned in the lens case base well, one haptic appears to be broken, the other haptic is deformed.The lens optic appears to be damaged/chipped.The origin of the observed damage cannot be confirmed based on the returned photo.The product was subject to handling and the reported damage was highlighted post implantation.The incision size indicated did not correlate to the recommended size for the cartridge used.It is unclear if this may have contributed to the reported event.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).
Event or Problem Description
Lens was removed during initial procedure and replaced with company lens.

• 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: 23534227
• Report Number: 9612169-2025-02269
• Device Sequence Number: 13308581
• Product Code: POE
• UDI-Device Identifier: 00380652405140
• UDI-Public: (01)00380652405140(17)280514(11)240516(10)25852745
• 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 Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.150
• Device Lot Number: 25852745
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/02/2026
• Date Device Manufactured: 05/16/2024
• 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: DISCOVISC; MONARCH III IOL, CARTRIDGE C
• Patient Sex: Unknown