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

Model Number	CC60WF
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that damaged lens was found inside the carton and the cartridge was split.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned pressed into the well area of the lens case.Viscoelastic was observed on the lens.Both haptics were folded in on the optic typical of loading into a cartridge.No lens damage was observed.The lens was cleaned with klrp.Very small chip was observed on anterior optic edge.No other damage observed.Lens dimensions were acceptable (plan view) using an approved template.Product history records were reviewed, and documentation indicated the product met release criteria.It is unknown if a qualified cartridge was used as the model was not specified.The company lens is only qualified for use in the company cartridge.The handpiece and viscoelastic used were not provided.It is unknown if qualified products were used.A very small chip was observed on the optic edge.No other damage was observed.Information was provided that the cartridges tip split.It is unknown if a qualified cartridge was used.The diopter lens is only qualified for use in the company cartridge.Lens dimensions were acceptable (plan view) using an approved template.If is unknown if a qualified cartridge, handpiece and viscoelastic were used.Per the instruction for use (ifu): company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.There have been no other complaints reported in the lot number.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: 15932151
• Report Number: 1119421-2022-02598
• Device Sequence Number: 4459875
• Product Code: HQL
• UDI-Device Identifier: 00380652397025
• UDI-Public: 00380652397025
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2022

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 Expiration Date: 11/22/2025
• Device Model Number: CC60WF
• Device Lot Number: 15312371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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
• Patient Age: 81 YR
• Patient Sex: Female