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

Model Number	CCWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Impairment (2138); Eye Pain (4467)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned adhered to a piece of white medical sponge material in a plastic bag.Viscoelastic was observed on the lens.The lens was cleaned with klrp to further evaluate.One haptic was broken in the gusset area.The broken haptic was returned.The optic was cut into pieces, typical of an insertions and removal.The optic posterior and anterior surfaces have parallel lines of cracked optic damage similar in appearance to damage from an instrument used to grasp the lens.Product history records were reviewed and documentation indicated the product met release criteria.The associated cartridge and handpiece information was not provided.It is unknown if qualified products were used.A nonqualified viscoelastic was indicated.The root cause cannot be determined for the reported complaint.The lens was returned cut into pieces, typical of an insertion and removal.Broken haptic damage was also 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 lens 17.5 diopter (add power +2.2/+3.2 diopter) was removed and replaced with a non-company monofocal 16.5 diopter lens.Due to the exchange of a multifocal for a monofocal lens, and one diopter less, this suggests that a monofocal may have been an improved choice for the patient's vision needs.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the patient experienced poor vision, and eye pain.The iol was exchanged for non-company monofocal model lens 01 month 03 days following the initial implant procedure.Additional information has been requested and received stating, distance vision and night vision was blurry.Pain and pressure are main complaints.In the surgeon's opinion the product did not contribute or cause pain and pressure but contributed or caused blurry vision and night vision.The iol was exchanged for non-company monofocal model lens 01 year 1 month 03 days following the initial implant procedure.The patient¿s issues were resolved.The surgeon¿s prognosis was good.No patient harm.
Additional Manufacturer Narrative
Correction information was provided in d.4.H.6.Correction: on initial mdr the fda evaluation codes of d10, d1101 was an error.It should have been d15 on the original mdr.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 20425567
• Report Number: 1119421-2024-01986
• Device Sequence Number: 7860630
• Product Code: MFK
• UDI-Device Identifier: 00380652413596
• UDI-Public: (01)00380652413596(17)260718(11)220720(10)15456002(21)15456002016
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2026
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.175
• Device Lot Number: 15456002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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: VISCOELASTIC: OCUCOAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male