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

Model Number	TFNT00
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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 facility representative reported that following an intraocular lens (iol) implant procedure, the an haptic was separated from the lens when opened and it was decided to implant it as there was no reserve.On checking the next day, it was observed that the lens was not stabilized in the capsular bag.The iol was exchanged for another lens model two months following the initial implant procedure.Additional information was requested.
Additional Manufacturer Narrative
Additional information was added in d.4., h.3.,h.6.And h.11.The sample was not returned.A photo was provided.The lens was observed placed posterior surface up into the base component of the opened lens case.A glare from overhead light was observed reflected on the lens.The lens clarity was blurry and upon magnification did not improve.There appeared to be viscoelastic on the lens.One haptic appeared to be broken from the optic.The broken haptic was not observed in this photo.Additional confirmations cannot be made without a physical sample.Product history records were reviewed and the documentation indicated the product met release criteria.The associated products are qualified for use with this lens.The root cause cannot be determined for the reported complaint of "haptic was separated from iol, lens not stabilized in capsular bag, explant".A sample was not available for return.A photo was provided.The photo displayed a broken haptic and what appeared to be viscoelastic on the lens in a lens case.Based on follow up information provided from the customer, the haptic was broken upon opening.The surgeon decided to implant it as there was no reserve.The surgery was completed to prevent capsular collapse, and it was decided to implant the defective lens to maintain the capsule.When the lens was checked the following day, it was observed that the iol had not stabilized in the capsular bag, making it necessary to replace the lens.The replacement lens information was not provided.File will be reopened if new information or the sample is received.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: 20394485
• Report Number: 1119421-2024-01965
• Device Sequence Number: 6566175
• Product Code: MFK
• UDI-Device Identifier: 00380652357784
• UDI-Public: (01)00380652357784(17)270213(11)220215(10)15354279(21)15354279083
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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 Model Number: TFNT00
• Device Catalogue Number: TFNT00.225
• Device Lot Number: 15354279
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/05/2024
• Date Device Manufactured: 02/15/2022
• 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 C.; MONARCH III IOL, INJECTOR.; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male