MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC UV ABSORBING IOL; INTRAOCULAR LENS

Model Number	CC60WF
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that the patient had a particle at corneal wound after cataract surgery in the right eye.It was presumed to be retained cortex.When it was removed in secondary procedure, the particle was felt to be hard and solid and seemed to be plastic material.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was added in h.3.,h.6.And h.11.The suspect lens and cartridge were not returned for evaluation.A particle was returned on the tip of a swab that was placed inside a specimen cup.The sample was sent to particle lab.Lab results: the returned eye spear was microscopically examined.A clear particle was found adhered to the eye spear.The particle was clear and approximately 1.8mm in length.The clear particle was then isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the particle¿s generated spectra to a library of spectra found the best match to be company cartridge base coat.Complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Qualified associated products were indicated.The root cause for the reports particle in the eye could not be determined.Only the particle was returned.The lens remains implanted.The particle lab testing indicated that the clear particle was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the particle¿s generated spectra to a library of spectra found the best match to be monarch cartridge base coat.The associated cartridge was not returned for evaluation.It cannot be determined if the associated cartridge sustained damaged during the lens delivery.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.In addition, the ifu states: follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL
• Common Device Name: 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: 20247449
• Report Number: 1119421-2024-01842
• Device Sequence Number: 7366141
• Product Code: HQL
• UDI-Device Identifier: 00380652396646
• UDI-Public: 00380652396646
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: CC60WF
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/09/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CENTURION VISION SYSTEM; CLAREON MONARCH IV IOL INJECTOR; MONARCH II LOADING FORCEPS; MONARCH III IOL CARTRIDGE D; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female