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
The product was 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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned.Viscoelastic is observed on the lens.The lens was cut into two pieces.Based on the provided photo, the cut is through the pictured small, cracked area.The crack cannot be visualized on the returned lens portions.The optic edge is also chipped.Photo #1 was indicated to be for this lens.The photo is of a multifocal single-piece lens in the eye.What may be a small crack is observed just off-center of the optic.A qualified cartridge and handpiece were indicated with a non-qualified viscoelastic.The root cause for the reported crack could not be determined.What appeared to be a small crack was observed in the provided photo.However, the returned lens had been cut into two pieces through the pictured area.No determination could be made.A non-qualified viscoelastic was indicated.Company foldable iol(intraocular lens)s are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu(instructions 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: 15830864
• Report Number: 1119421-2022-02442
• Device Sequence Number: 12091273
• 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: 15347045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• 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): Yes
• Date Device Manufactured: 02/14/2022
• 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