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

Model Number	TFNT00
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, after the iol was loaded and injected into the capsular bag a fissure was observed in the central area of the lens.The iol was removed and the incision was enlarged.In the process the haptic also ruptured.The procedure was completed with the same iol model and power.Additional information was received and reported that there was no harm to the patient.
Additional Manufacturer Narrative
The lens was returned in a small glass container.Solution was observed, on the lens.One haptic was broken/torn from the haptic/optic junction area (returned).The optic has a torn/split/cracked area, near the central optic zone.A qualified cartridge was indicated.The handpiece and viscoelastic were unspecified.It is unknown, it qualified products were used.The reported lens damage was observed.All lenses are 100% inspected for cosmetic attributes.And the damage exhibited by the returned complaint sample would not have met companies release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded, that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely, related to customer handling.Not enough information was provided to determine, if a qualified handpiece and 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 ¿ iol delivery system or any other company qualified combination.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 ; 8175514979
• MDR Report Key: 12487402
• Report Number: 1119421-2021-01771
• Device Sequence Number: 3349837
• Product Code: MFK
• UDI-Device Identifier: 00380652357791
• UDI-Public: 00380652357791
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 11/24/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.230
• Device Lot Number: 15116709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• 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: MCPHERSON - FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; UNK INJECTOR; UNK VISCOELASTIC; MCPHERSON - FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; UNK INJECTOR; UNK VISCOELASTIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown