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)
Date of Event	09/25/2023
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 had distance vision blurry, bothered by night vision, pain and pressure.The iol was exchanged for non-company lens.There was no patient harm.Additional information has been requested.
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).
Additional Manufacturer Narrative
Correction information was provided in d.4.Additional information was added in d.9.,h.3., h.6., and h.11 the lens was returned with a small piece of white medical sponge in a plastic bag.Viscoelastic was dried on the lens.The optic was cut into pieces, typical of insertion and removal.The optic has long cracks across the optic.The optic has scratches and scrapes between the optic center and the optic edge.A group of three scratches were observed on the anterior optic surface near the edge.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge was used.The specific name of the associated handpiece was not provided; however, the questionnaire response for the selection of handpiece used was, "other".This answer would indicate that a non-qualified handpiece was used.A non-qualified viscoelastic was also indicated.The root cause cannot be determined for the reported complaint.The explanted lens was returned in pieces with additional optic damage.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.The non-toric company lens ccwtt0 18.0 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company multi focal lens 16.75 diopters.This information that a multifocal lens was exchanged for a non-company multifocal lens that was 1.25 diopters less than the original implant may suggest that the diopter selection of the replacement lens was an improved selection for this patient's vision needs.File will be reopened if new information is received.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: 20127207
• Report Number: 1119421-2024-01686
• Device Sequence Number: 14228437
• Product Code: MFK
• UDI-Device Identifier: 00380652413602
• UDI-Public: (01)00380652413602(17)261008(11)221010(10)15500737(21)15500737013
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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 Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.180
• Device Lot Number: 15500737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/03/2024
• Date Device Manufactured: 10/10/2022
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.; OCUCOAT OVD.; REPLACEMENT LENS: SBL-3 16.75, SN (B)(6).; UNSPECIFIED HANDPIECE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male