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

Model Number	SY60WF
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that an intraocular lens (iol) was advanced with plunger upside down and the doctor worried that lens was scratched during surgery.The lens was removed from eye.There was no patient harm.The originally scheduled procedure was completed the same day.
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
Additional information was provided in h.3., h.6.And h.10.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a non-qualified cartridge.The handpiece and viscoelastic indicated are qualified for use with this lens with the use of qualified lens/cartridge combinations.The root cause is most likely related to a failure to follow the ifu.The account used an unqualified lens/cartridge combination.The company lens model in only qualified for use in the company cartridge up to 25.0 diopters.Company foldable iols are qualified for use with a 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 HYDROPHOBIC ACRYLIC 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: 17972620
• Report Number: 1119421-2023-01790
• Device Sequence Number: 5118959
• Product Code: HQL
• UDI-Device Identifier: 00380652251594
• UDI-Public: 00380652251594
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 12/06/2023

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: 06/28/2026
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.255
• Device Lot Number: 15439462
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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 IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 66 YR
• Patient Sex: Male