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

Model Number	CCWTT4
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An ophthalmic surgeon reported that during a cataract extraction with intraocular lens (iol) implant procedure, a long (2.5mm) blemish was observed, central anterior on the iol.Attempted to aspirate the blemish was initially with irrigation and aspiration and did appear to remove some of the blemish.A central scratch still appeared and physical contact with sinsky type instrument was used to try and remove blemish, as well as continued aspiration, but was not effective.Lens was then exchanged.Additional information was received stating the blemish on the iol was located on the central anterior side.It was originally an approximately 1.5-2.0 mm blemish in a line.After copious irrigation and manipulation trying to remove, some of the blemish was removed; however, an approximate 1mm line was still on the iol and could not be revived.
Additional Manufacturer Narrative
A sample device was not returned for analysis.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).
Additional Manufacturer Narrative
A photo was provided of the lens in the eye.The lens is a single-piece, multifocal toric.A dark mark is observed near the center of the lens.Unable to determine if this is a crack or a scratch from the photo.Associated products were not provided.It is unknown if qualified associated products were used.The product investigation could not identify a root cause for the reported complaint.Company foldable intraocular lenses 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 intraocular lens and potential complications during the implantation process.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: 15495686
• Report Number: 1119421-2022-02078
• Device Sequence Number: 6090860
• Product Code: MJP
• UDI-Device Identifier: 00380652457866
• UDI-Public: 00380652457866
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/06/2022

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: 03/30/2025
• Device Model Number: CCWTT4
• Device Catalogue Number: CCWTT4.175
• Device Lot Number: 15301510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 11/12/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2021
• 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, INJECTOR; MONARCH III IOL, CARTRIDGE D; PROVISC; SINSKY TYPE INSTRUMENT
• Patient Sex: Unknown