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

Model Number	CC60WF
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that, during intraocular lens implantation surgery, the physician noticed that there was a white spot in the optic.Hence the lens was discarded and another lens was implanted in the same procedure.Additional information was requested, but no further information is available.
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
The lens was returned in the lens case.Viscoelastic was observed on the lens.Both haptics were broken; one gusset area and one distal area (not returned).The lens had two very large scrape marks on the posterior surface near the edge.The scraped areas have material removed and have a white appearance due to the damaged material.This damage was most likely interpreted as the reported "white spot.Product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified associated products were used.The returned lens had two very large scrape marks on the posterior surface near the edge.The scraped areas have material removed and have a white appearance due to the damaged material.This damage was most likely interpreted as the reported "white" spot.This type damage is known to occur if the lens is advanced too rapidly with inadequate viscoelastic in the cartridge.The instruction for use (ifu) instructs to completely fill the cartridge with ophthalmic viscosurgical devices (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.Use the company cartridge at operating room temperatures between 18° c (64° f) and 23° c (73° f).It is unknown if qualified associated products were used.The ifu instructs: company foldable intra ocular lens (iol) 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 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: 17469298
• Report Number: 1119421-2023-01402
• Device Sequence Number: 7121274
• Product Code: HQL
• UDI-Device Identifier: 00380652396776
• UDI-Public: 00380652396776
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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: CC60WF
• Device Lot Number: 15554143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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
• Patient Sex: Unknown