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

Model Number	CCWET3
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry, slight toric rotation and under correction of astigmatism.The iol was exchanged for another lens model 1 months 6 days following the initial implant procedure.The surgeons prognosis was mentioned as good.
Additional Manufacturer Narrative
The lens was returned on wet, white medical sponge material inside a large biohazard bag.The lens was removed and allowed to dry prior to evaluation.Residue of solution was observed on the lens.The optic was cut into 3 pieces, typical of damage created to remove a lens from the eye.One optic portion containing one full haptic was undamaged.The middle cut optic portion had splintering crack damage from the line of cut damage.The optic edge was split.The third optic portion containing the other full haptic was cracked in the haptic/optic junction on the anterior surface.The optic was cracked in two areas on the posterior and cracked on the anterior near the line of cut optic damage.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that a qualified cartridge, handpiece, and viscoelastic were used.The product investigation could not identify a root cause for the reported complaint of slight toric rotation and under correction of astigmatism.The explanted lens was returned cut into pieces, typical of damage created to remove a lens from the eye.Additional lens damage was observed.Each lens was subjected to a 100% 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 (1.50 cyl) 15.5 diopter lens was removed and replaced with a company (2.25 cyl.) 15.5 diopter lens.The exchange from a company (1.50 cyl) to a company (2.25 cyl.) would suggest that the replacement lens model was an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 19181658
• Report Number: 1119421-2024-00801
• Device Sequence Number: 20686056
• Product Code: MJP
• UDI-Device Identifier: 00380652455190
• UDI-Public: 00380652455190
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 04/25/2024

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 Expiration Date: 02/19/2026
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.155
• Device Lot Number: 15354727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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 MONARCH IV INJECTOR.; MONARCH III CARTRIDGE D.; ORA SYSTEM WITH VERIFEYE MESSAGING.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male