MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFNT30
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported that, following the intraocular lens (iol) implant procedure, patient was +5.75 after refractive lens exchange (rle) and emmetrop on the other eye, so the suspicion is that the lens had the wrong power (the scanned barcodes say that the information on the package matched what was planned).It was also reported that there was something wrong with one of the lenses.The patient has received a new lens.The patient was not harmed.Additional information received and stated that, the patient came back for a scheduled follow-up and reported bad vision the patient had 5.75 diapter issue and was verified under examinations during the follow-up.The lens was explanted in a secondary procedure.The patient was not harmed and after the implant the sight was good.
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
The lens was returned in the replacement lens case and carton (same lot/model/diopter company lens, 23.0).Viscoelastic was dried on the lens.The lens had been cut from one edge into center.The lens was cleaned with klrp.Power and resolution testing was conducted by engineering.Measurements were difficult to verify due to the extensive optic damage.Based on the obtainable readings, the returned lens did not meet the specifications for a company, 23.0 diopter lens.A root cause analysis was conducted, and the most likely root cause was determined.The complaint lens introduction most likely occurred at the toric lens bench operation when the complaint batch was being cased.The presence of this complaint lens was likely the result of an operator handling issue and/or failure of the line clearance process.The root cause was determined to be inadequate process with a line clearance failure considered to be a contributing factor.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• 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: 17975662
• Report Number: 1119421-2023-01799
• Device Sequence Number: 11642303
• Product Code: MFK
• UDI-Device Identifier: 00380652390033
• UDI-Public: 00380652390033
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2025
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30.230
• Device Lot Number: 15093798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/12/2023
• Date Device Manufactured: 08/25/2020
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown