MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
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 non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced with poor night experience/night driving vision in right eye.The lens was exchanged for another lens model 02 months 23 days following the initial procedure.Additional information has been requested.
Event or Problem Description
Additional information was received, there was no patient harm and patient issues were resolved.
Additional Manufacturer Narrative
Correction information provided in b.2.Additional information provided in a.2., a.3.A., b.5., b.6., b.7., d.9., d.10., e.4., h.3., h.6.And h.11.The lens was returned submerged in clear solution inside a plastic specimen jar placed into a large biohazard bag.The lens was removed from the liquid and allowed to air dry.Patterns of residual viscoelastic were observed on the lens.One haptic was broken in the gusset area.The broken haptic was not returned.The optic was broken in jagged lines of damage into pieces.Only two pieces were returned.The optic has splintering tears, cracks and scratches that emanates from the jagged line of damage to the optic.The optic edge of one portion has a semi-circle area that was cracked.Another optic portion was torn from the edge toward the center.Another edge area was observed to be split and scraped at the end of the split damage, located on the posterior surface.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified cartridge and viscoelastic were indicated.The handpiece information was unknown.It is unknown if a qualified handpiece was used.The root cause cannot be determined for the reported complaint.Each lens was subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Information was provided that the company 17.0 diopter (1.5 extended depth of focus) lens was removed and replaced with a company another model 16.5 diopter lens.Due to the exchange of a company 17.0 diopter (1.5 extended depth of focus) lens for a monofocal company another model 16.5 diopter lens, this suggests that the replacement lens may have been an improved choice for the patient's vision needs.File will be reopened if new information is received.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 RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21158652
• Report Number: 1119421-2025-00177
• Device Sequence Number: 15588223
• Product Code: POE
• UDI-Device Identifier: 00380652405188
• UDI-Public: (01)00380652405188(17)260614(11)220616(10)15431619
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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 Expiration Date: 06/14/2026
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.170
• Device Lot Number: 15431619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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: CLAREON IOL; DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; ORA SYSTEM WITH VERIFEYE MESSAGING; UNK REUSABLE HANDPIECE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male