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

Model Number	TFNT00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during implantation of an intraocular lens (iol) the first lens was injected with no difficulty into the eye, noted a linear crack near the centre of the optic and removed it.Opened the spare lens, had a quick look under the microscope but didn't see any crack in the lens (i have to say that i didn't view it under high magnification).Loading and injection of lens was easy with no issue.Once again, saw the same linear crack near the centre of the optic.Didn't have any more lens so i left it in the eye following a discussion with the patient.There was no resistance with the latter and lens went in smoothly.I have used the injector many times in the past with no issue.Additional information was requested and received sating there was no patient harm.
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Photo was provided.Photo #2 was indicated to be the implanted lens.The photo showed a multifocal single-piece lens in the eye.What appeared to be a crack was observed off center of the optic.The crack was perpendicular to the fold path.This is similar in appearance to damage that may occur if there is a plunger over/under ride of the optic during delivery.A qualified cartridge and handpiece were indicated with a non-qualified viscoelastic.The root cause for the reported crack could not be determined.The lens remains implanted.What appeared to be a crack was observed in the provided photo.The area was similar in appearance to damage that may occur if there is a plunger over/under ride of the optic during delivery.A determination could not be made from the photo.A non-qualified viscoelastic was indicated.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu(instruction for use) 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 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: 15830896
• Report Number: 1119421-2022-02443
• Device Sequence Number: 5103615
• Product Code: MFK
• UDI-Device Identifier: 00380652357791
• UDI-Public: 00380652357791
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: 15382977
• 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: 10/24/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 11/19/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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; MONARCH IOL , INJECTOR; VISTHESIA
• Patient Age: 45 YR
• Patient Sex: Female