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

Model Number	CCWTT3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that following insertion of the intraocular lens (iol), the lens had inclusion in optic of lens and the patient unable to refract past 20/60.Additional information has been requested.
Additional Manufacturer Narrative
A sample device 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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
An attached photo appears to be a lens in the eye.There appears to be some slight damage across the lens just below a big bright streak of light.However, because the reflection of the light source is so bright, the details of the possible damage cannot be confirmed.Associated product information was not provided it is unknown if qualified products were used.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.Associated product information was not provided.It is unknown if qualified products were used with the lens.The ifu (instructions for use) instructs that an 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.Company recommends using the qualified company iol (intraocular lens) delivery system or any other company qualified combination.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received.And stated that, the lens was explanted in a secondary procedure.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned in a small opened container in a plastic bag.Viscoelastic was dried on the lens.The lens was cleaned with klrp to further evaluate.After removal of the clinical solution, the lens was allowed to air dry prior to evaluation.The optic anterior has a light scratch observed located across the optic rings.A power and resolution test was conducted by engineering lead technician.The optic resolution was acceptable; the lens met specification readings for a company model focal length 23.0 and cylinder 1.50.A light scratch was observed on the optic surface.This damage was most likely interpreted as the reported complaint.Also, each lens is 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.A power and resolution test was conducted using the explanted lens and the lens met specification for a company model 23.0 diopter lens.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned explanted sample, the damage is most likely related to customer handling.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL 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: 15732907
• Report Number: 1119421-2022-02351
• Device Sequence Number: 20720679
• Product Code: MJP
• UDI-Device Identifier: 00380652457446
• UDI-Public: 00380652457446
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/21/2023

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 Expiration Date: 01/23/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.230
• Device Lot Number: 15338785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 12/14/2022; 01/20/2023; 02/22/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/05/2023; 02/14/2023; 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown