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

Model Number	TFNT00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A surgeon reported that during an cataract surgery with intraocular lens (iol) implant procedure, scratch was found on iol optic after implantation.Scratch was still there after irrigation and aspiration.The surgery was completed without iol exchange.The patient had not claimed any decrease in the sight ability.Additional information has been requested; however, further information has not been received.
Additional Manufacturer Narrative
Information in the file indicated that the lens remains in the eye.Two photos were available (on a powerpoint slide).The photos show the lens while inside the eye.There appeared to be a scrape or tear on the optic edge, with a travel path toward the optic center.It cannot be confirmed from the photo if the damage was on the optic posterior or anterior edge.Information was provided that a qualified company cartridge and qualified company handpiece were used with the lens.A non-qualified viscoelastic was used with the qualified combination.Non company product is not qualified for use with the company handpiece.Based on the photos in the file, the reported damage was observed.The sample was not returned.The lens remains in the eye.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used.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.Company recommends using the qualified company intraocular lens (iol) delivery system or any other company qualified combination.Also per the company ifu: the qualified cartridge/iol combinations have been validated at an ambient temperature of 18 °c using the driving console setting (1.7 mm/sec, 3 seconds, and 3.0 mm/sec for initial velocity, pause and final velocity respectively).Using a higher velocity and shorter pause at lower temperatures, especially with high diopter lenses, could induce damage to iol and/or iol cartridge, affecting successful iol implantation.Attempts were requested and made for follow up to try to clarify a serial number for this lens.No further information has been provided.If additional information becomes available, the file will be reopened and updated.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX 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: 13072145
• Report Number: 1119421-2021-02444
• Device Sequence Number: 14860528
• Product Code: MFK
• UDI-Device Identifier: 00380652357791
• UDI-Public: 00380652357791
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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 Model Number: TFNT00
• Device Catalogue Number: TFNT00.230
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: HEALON; INTREPID HANDPIECE; MONARCH CARTRIDGE D
• Patient Sex: Unknown