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

Model Number	CC60WF
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, a partial fracture or crack through central optic.High effort during initial injection, but then smoothed out.It was reported that uneventful lens loading.The lens explanted and replaced immediately during initial procedure.Additional information has been requested.
Additional Manufacturer Narrative
The account indicated the use of a qualified associated cartridge.The handpiece indicated is not qualified for use with the lens/cartridge used.Company lens models are only qualified for use with the company handpiece.Viscoelastic was not provided.It is unknown if a qualified product was used.The root cause is most likely related to a failure to follow the ifu (instructions for use).The account used an unqualified lens/cartridge/handpiece combination.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.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: 16528012
• Report Number: 1119421-2023-00440
• Device Sequence Number: 2645885
• Product Code: HQL
• UDI-Device Identifier: 00380652396950
• UDI-Public: 00380652396950
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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: 02/12/2026
• Device Model Number: CC60WF
• Device Lot Number: 15351679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III CARTRIDGE C.; MONARCH III CARTRIDGE C.; MONARCH III INJECTOR.; MONARCH III INJECTOR.
• Patient Sex: Unknown