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 Codes	Material Opacification (1426); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, there was smudge on the lens.Subsequently, it was removed during initial procedure and completed with new iol.Additional information was received and no patient harm reported.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge and qualified handpiece.A non-qualified viscoelastic was indicated.The product investigation could not identify a root cause for the reported complaint.The file indicated that the lens was not returning.It cannot be confirmed based on the provided information if the reported complaint was a foreign material or potentially lens damage interpreted as a "smudge on the lens".A failure to follow the ifu (instructions for use) occurred with the use of a non-qualified viscoelastic.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an 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 company ( 1.50 cyl.) 19.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with another company ( 1.50 cyl.) 19.5 diopter (add power +2.2/+3.2 diopter) lens.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned in a plastic bag with a surgical sponge.Solution was dried on the lens.The optic was cut into pieces, typical of insertion and removal.One cut optic portion had a deep scrape mark between the cut damaged area and the optic edge.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicated the use of a qualified cartridge and handpiece with a non-qualified viscoelastic.The root cause for the reported complaint appears to be related to failure to follow the ifu.The file indicated the use of a viscoelastic that is not qualified for the product combination used.The ifu instructs that an alcon 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 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: 18381549
• Report Number: 1119421-2023-02189
• Device Sequence Number: 15381833
• Product Code: MJP
• UDI-Device Identifier: 00380652457378
• UDI-Public: 00380652457378
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2024

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 Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.195
• Device Lot Number: 15639004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 02/08/2024; 06/19/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 03/05/2024; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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 IOL; OCCUCOAT VISCOELASTIC
• Patient Age: 59 YR
• Patient Sex: Male