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	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2024
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A consumer reported during intraocular lens (iol) implant procedure, when using the company injector to place the lens, lens was scratched, and notched on both periphery and center area.The lens was broken into half and explanted.Replaced with back up company lens with unspecified diopter during initial procedure.The procedure was completed.Additional information has been requested.
Additional Manufacturer Narrative
Correction information was provided in d.4.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned positioned incorrectly in the lens case inside the lens carton.Viscoelastic was observed on the lens.One haptic was broken in the gusset area.The broken haptic portion was not returned.The optic was broken (or cut) into two pieces, typical of an insertion and removal.An area of the optic along the line of damage was also broken.The optic material of this broken area was not returned.The posterior optic surface has a line of scratches near the edge.The optic anterior surface has a line of cracked damage near the optic center and near the optic edge.Product history records were reviewed, and the documentation indicated the product met release criteria.The account indicated the use of qualified associated products.Root cause: the reported lens damage was observed.The product investigation could not identify a root cause for the reported complaint.The instructions for use (ifu) instructs to completely fill the cartridge with ophthalmic viscosurgical device (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The ifu 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.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.Information was also provided that the lens was broken in half to remove the lens.The company 23.0 diopter was removed and replaced with an unspecified company lens.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 20508190
• Report Number: 1119421-2024-02042
• Device Sequence Number: 12758308
• Product Code: POE
• UDI-Device Identifier: 00380652405300
• UDI-Public: (01)00380652405300(17)280330(11)240401(10)15830420(21)15830420011
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2025

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: CNWET0.230
• Device Lot Number: 15830420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/23/2024; 12/10/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/21/2024; 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: ACRYSOF IQ VIVITY EXTENDED VISION IOL.; CLAREON MONARCH IV IOL INJECTOR.; DUOVISC OVD.; MONARCH III IOL CARTRIDGE D.
• Patient Age: 60 YR
• Patient Sex: Unknown