MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCWET0
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
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 non-healthcare professional reported with during an intraocular lens (iol) implant procedure, the intraocular lens was scratched and the surgeon inserted wrong diopter for the patient.The lens was removed during initial procedure.There was no patient harm.Additional information has been requested.There are two medical device reports associated with this report.This is 2 of 2.
Additional Manufacturer Narrative
Correction information was provided in d.4.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.5., h.3., h.6., and h.11.The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.A qualified company cartridge was indicated.It is unknown if a qualified handpiece and viscoelastic were used.Information was provided by the facility that the wrong lens was implanted for the patient.The non toric company model, 22.0 diopter lens was replaced with a toric company model (2.25cyl), 22.5 diopter lens.In addition they indicated that the technician loaded the lens wrong and scratched it.The product was not available for return.It is unknown if a qualified handpiece and viscoelastic were used.The instructions for use (ifu) instructs company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The customer provided the available information on the returned questionnaire.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that surgeon inserted wrong diopter for patient.
Additional Manufacturer Narrative
Corrected information provided in h.6., h.11.In smdr2, the evaluation result code c13 and the evaluation conclusion codes d1101 and d11 were mistakenly omitted.These have been submitted in smdr3.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 20293227
• Report Number: 1119421-2024-01899
• Device Sequence Number: 8012471
• Product Code: POE
• UDI-Device Identifier: 00380652405812
• UDI-Public: (01)00380652405812(17)270607(11)230609(10)15659733(21)15659733038
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.220
• Device Lot Number: 15659733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 10/25/2024; 11/21/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/23/2024; 11/21/2024; 12/19/2024
• Date Device Manufactured: 06/09/2023
• 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 CARTRIDGE D.
• Patient Sex: Unknown