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

Model Number	TFNT40
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, physician noticed a square tear at 12-1 o¿clock midperipheral in optics.Additional information has been requested and received stated that the crack runs in l shape, patient vision is not bothered by it.No further information available.
Additional Manufacturer Narrative
Three photos were provided which show the same view with slightly different lighting.The photos showed a single-piece multifocal toric lens in the eye.A narrow linear mark was observed which may be a scratch or a crack.The damage appears to be on the anterior optic surface.The damage is perpendicular the lens travel path.Damage to the anterior surface may be caused during loading by an instrument used to grasp the lens.Damage to the anterior surface may also be caused if a plunger override occurs.No determination can be made based on the photos.The handpiece and cartridge used were not provided.It is unknown if qualified products were used.The indicated viscoelastic is not qualified for use with company delivery systems.Root cause: the product investigation could not identify a root cause for the reported complaint.The lens remains implanted with no visual impact for the patient.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.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: 16724236
• Report Number: 1119421-2023-00641
• Device Sequence Number: 7967606
• Product Code: MFK
• UDI-Device Identifier: 00380652390552
• UDI-Public: 00380652390552
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2023

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: TFNT40
• Device Catalogue Number: TFNT40.215
• Device Lot Number: 15445197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• 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: PROTECTALONE 1.4%
• Patient Age: 72 YR
• Patient Sex: Male