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

Model Number TFNT00

Device Problems Defective Device (2588); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2023

Event Type  malfunction  

Event Description

A healthcare professional reported that, during intraocular lens implantation surgery, the physician noticed that the haptic of the lens was broken.The physician implanted the same lens into the patient's eye and post operative day 1, the lens was decentered.The physician has planned to explant the lens.Additional information has been requested, received and stated the lens has been explanted and the patient was recovered.

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).

Manufacturer Narrative

The product was not returned.A photo and a video were provided which showed the company cartridge inserted into a non-company handpiece.The plunger was fully retracted.Viscoelastic was observed in the cartridge.The cartridge appeared fully seated in the handpiece.A yellow single-piece, broken haptic was observed in the cartridge at the parting line.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge was indicated with non-qualified handpiece and viscoelastic.The product was not returned.A photo and video were provided which showed the broken haptic inside the cartridge nozzle.The cartridge was shown inserted in a non-company handpiece.The handpiece plunger was fully retracted.The haptic position relative the plunger during advancement cannot be determined due the plunger retraction.The video did not show the lens loading or advancement.The root cause may be related to a failure to follow the instructions for use (ifu).A non-company handpiece and viscoelastic were used.The ifu instructs: company foldable iols are qualified for use with the company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.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 ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.Information was provided that the lens was replaced and the patient has recovered.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Type of Device: 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: 18198987
• MDR Text Key: 328884209
• Report Number: 1119421-2023-01975
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 00380652357777
• UDI-Public: 00380652357777
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.220
• Device Lot Number: 15606105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 2% METHYLCELLULOSE.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; ROYAL INJECTOR.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male