MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT3
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that while positioning the intraocular lens (iol) during implantation procedure, it appeared that a section of the iol was missing.Therefore, the lens was cut into two pieces and removed.The surgery was completed using backup lens.There was no patient harm.Additional information received stated that the iol was cut into two pieces and removed from patient's right eye.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.One haptic was broken in the gusset area (not returned).The optic was torn/split/cracked (possibly cut) into pieces.The optic edge was chipped with lens material missing (not returned).The account indicated the use of a qualified associated cartridge and handpiece.The viscoelastic indicated is not qualified for use with this lens with any of the qualified lens/cartridge combinations.The reported lens damage was observed.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).The viscoelastic indicated is not qualified for the lens/cartridge combination used.The ifu instructs that a 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 product has not been received to evaluate.File will be reopened when product is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 16654563
• Report Number: 1119421-2023-00562
• Device Sequence Number: 6071476
• Product Code: MJP
• UDI-Device Identifier: 00380652457415
• UDI-Public: 00380652457415
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/17/2023

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: 04/09/2025
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.215
• Device Lot Number: 15301533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; HEALON; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Sex: Unknown