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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Diplopia/Double Vision (4802)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in a plastic bag.Viscoelastic was dried on the lens.One haptic was broken/cut in the gusset area.The broken haptic was returned.The optic was cut into pieces, typical of damage created to facilitate removal from the eye.Only one half of the optic with the attached haptic was returned.This optic portion has small cracked and split damage near the optic edge.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge with a non-qualified handpiece and two non-qualified viscoelastics.The root cause cannot be determined for the reported complaint.A facility representative reported an explanted iol with patient reason "double vision especially looking at lights".The clinical reason was indicated as "subluxation of lens".Only portions of the explanted lens was returned.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) 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 company lens (1.50 cyl.) 20.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a company lens 21.5 diopter (add power +2.2/+3.2 diopter) lens.This information of an exchange from a multifocal toric to a multifocal non-toric lens would reasonably suggest that the replacement lens model was an improved selection for this patient's vision needs.Multiple follow up attempts were made for more information.No further information has been provided.If additional information becomes available, the file will be reopened and updated.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 double vision especially looking at lights, subluxation of lens, explanted iol and replaced with 215 monofocal lens model.Additional information has been received and stated that the patient has double or triple vision especially looking at lights.In the surgeon¿s opinion a quality issue with the iol cause or contributed to the event and surgeon¿s prognosis was good.The patient¿s issues were resolved.

• 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: 18745994
• Report Number: 1119421-2024-00320
• Device Sequence Number: 8344459
• Product Code: MJP
• UDI-Device Identifier: 00380652457392
• UDI-Public: 00380652457392
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.205
• Device Lot Number: 15571003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: AMVISC, ENDOCOAT; CLAREON PANOPTIX TRIFOCAL UV ABSORBING IOL; MONARCH II IOL DELIVERY SYSTEM, INJECTOR; MONARCH III IOL CARTRIDGE C
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male