MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.¿ 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 nurse reported that, during intraocular lens implant procedure, deemed not implantable due to surgeon noticed a black smudge on the lens after implantation.The issue was noted after the lens was implanted.The lens was cut out and a new lens was implanted.Additional information was requested, but further no information was available.
Additional Manufacturer Narrative
The lens and lens case were not in the returned lens carton.Only the implant reply card, patient id card, part of the additional label set with an empty company cartridge pouch were returned.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic and cartridge were indicated.The handpiece information was not provided.It is unknown if a qualified product was used.The root cause could not be determined.No determination can be made without physical evaluation of the complaint sample.It cannot be determined if the reported "smudge" was lens damage.It is unknown if a qualified handpiece was used.Per the instructions for use (ifu): the company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable intraocular lenses.Company foldable intraocular lenses 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 intraocular lens and potential complications during the implantation process.The instructions for use (ifu) also instructs: follow the section regarding directions for use for information on the maximum allowed time for the intraocular lens to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in intraocular lens damage.Note: during lens loading and insertion, do not allow the company intraocular lens to remain in a folded condition within the selected intraocular lens delivery system for more than 3 minutes prior to completing insertion into the capsular bag.There are no other complaints for the reported lot.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 15603111
• Report Number: 1119421-2022-02171
• Device Sequence Number: 2136958
• Product Code: MFK
• UDI-Device Identifier: 00380652408110
• UDI-Public: 00380652408110
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 12/02/2022

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: 01/22/2025
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.195
• Device Lot Number: 15258221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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: MONARCH III IOL, CARTRIDGE D; PROVISC
• Patient Sex: Unknown