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

Model Number	CCWET0
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, resistance was noticed on insertion.The procedure was completed on the same day without any harm to the patient.Additional information was requested and received stating that in the surgeon's opinion, the product caused or contributed to the event.The plan was to use a different model from the same company cartridge on 25.0 diopter and above moving forward.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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 with the extra labels set.Viscoelastic was dried on the lens.The optic was cut into two pieces, typical in appearance to damage from insertion and removal.The lens was cleaned with klotho-related protein (klrp) to further evaluate.One optic portion has a small area and a larger area of the edge that was broken.The optic material of the larger broken area was returned.Scratches and scrape marks were observed on the anterior and posterior optic surfaces near the smaller broken optic area.The anterior and posterior optic surfaces were cracked extending into the optic material from the larger broken optic edge area.Another edge area was split and cracked on the anterior and posterior surfaces.The other optic portion has posterior damage in two areas of the attached haptic.One distal area of the haptic was scraped and the other area was split.The optic edge was split and cracked on the anterior and posterior surface.Another small area was cracked on the anterior and posterior.A third area was cracked near the center with several scuff marks.A device 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.A non-qualified cartridge and non-qualified viscoelastic were used with this lens.A handpiece was indicated that would be qualified when used with a qualified product combinations.The lens was returned cut into pieces, typical of an insertion and removal.Additional lens damage was observed.The root cause for the reported complaint is most likely related to a failure to follow the instructions for use (ifu).A non-qualified cartridge non-qualified viscoelastic was used.This diopter (25.5) of the company lens model is beyond the range (6.0 through 25.0 diopter) qualified for use in the company cartridge.The ifu instructs: company foldable intraocular lenses (iols) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.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.The ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer's recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the clareon 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.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22716629
• Report Number: 1119421-2025-02148
• Device Sequence Number: 13053696
• Product Code: POE
• UDI-Device Identifier: 00380652405881
• UDI-Public: (01)00380652405881(17)280207(11)240209(10)15793460
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: CCWET0
• Device Lot Number: 15793460
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; MCPHERSON/LENS LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; VISCOELASTIC STABLEVISC.
• Patient Sex: Male