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	Visual Impairment (2138)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A facility representative reported that following the intraocular lens (iol) implant procedure, the patient was unhappy with their vision.The lens was exchanged for a different model and diopter of the same company's lens after the initial implant procedure.No vitrectomy was performed but suture of incision or wound needed.The capsule bag remained intact.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned inside a sealed non-company sterilization pouch.The pouch was opened to evaluate the lens.The lens was adhered to the adhesive sides of a label.Viscoelastic was observed on the lens.The optic was broken and cut into pieces, typical of an insertion and removal.The larger of the broken optic portions was split and torn across the rings, through the central optic zone.Additional small, cracked damage was observed to the optic on the anterior and posterior.The anterior optic surface was also scratched between the outer rings and the outer edge.All product and batch history records are quality reviewed prior to product release.A qualified cartridge, handpiece, and viscoelastic were indicated.The root cause cannot be determined for the reported complaint.Each lens was subjected to a 100 percent 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 questionnaire response indicated that the patient was unhappy with vision.The multifocal toric company (1.50 cylinder) 22.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a multifocal non-toric company 23.0 diopter (add power +2.2/+3.2 diopter) lens.This information that a multifocal toric lens was exchanged for a multifocal non-toric lens would reasonably suggest that the complaint may be unrelated to the product and that the replacement lens was an improved selection for this patient's vision needs.File will be reopened if new information is received.

• 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: 20178392
• Report Number: 1119421-2024-01762
• Device Sequence Number: 15686180
• Product Code: MJP
• UDI-Device Identifier: 00380652457439
• UDI-Public: (01)00380652457439(17)250321(11)211028(10)15292248
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: 03/21/2025
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.225
• Device Lot Number: 15292248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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 PANOPTIX TRIFOCAL UV ABSORBING IOL.; MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; ORA SYSTEM WITH VERIFEYE MESSAGING.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female