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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/29/2024
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 wants to optimize distance vision without losing near vision.The iol was exchanged for non-company lens.There was no patient harm.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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information was provided in d.4.,d.10.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 portions have cracks into the lens material on the anterior and the posterior surfaces near the central optic zone.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 present across the anterior and posterior surfaces of the lens.The toric lens (1.50 cyl.) 22.0 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company monofocal toric 22.0 diopter lens.The initial report indicated that a facility representative reported an explanted iol with patient reason is wants to optimize distance vision without losing near vision.The information that a multifocal toric was removed and replaced with a monofocal toric of the same diopter would suggest that the monofocal 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 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: 20127232
• Report Number: 1119421-2024-01687
• Device Sequence Number: 3265495
• Product Code: MJP
• UDI-Device Identifier: 00380652457422
• UDI-Public: (01)00380652457422(17)270509(11)230511(10)15645933(21)15645933009
• 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: 2024
• 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): 10/01/2024

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: CCWTT3
• Device Catalogue Number: CCWTT3.220
• Device Lot Number: 15645933
• 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: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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; OTHER HANDPIECE; REPLACEMENT: ODYSSEY TORIC, ORT150 +22.0D; UNSPECIFIED HANDPIECE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male