MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT4

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2022

Event Type  malfunction  

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, some hard dried material at the posterior surface of the intraocular lens.The foreign material was aspirated away but leaving minimal residue on the intraocular lens.No more information available.

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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was not returned for evaluation.A photo was provided of a single-piece toric monofocal lens in the eye.A narrow linear mark/material can be observed, which appears to be on the posterior surface of the lens.The area originates near the axis marks.Other areas are observed, which may be ovd (ophthalmic viscosurgical device) or possible damage.No determination, can be made as to the nature or origin of the material from the photo.A qualified cartridge was indicated.The handpiece and viscoelastic used were not provided.It is unknown, if qualified products were used.The root cause for the reported, complaint could not be determined.The product and linear material were not returned for evaluation.No determination, can be made without physical evaluation of the complaint sample.No determination, can be made as to the nature or origin of the material from the provided photo.It is unknown, if a qualified handpiece and viscoelastic were used.Per, the ifu (instructions for use): company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications, during the implantation process.The ifu also, instructs to completely fill the cartridge with ovd (diagram provided) immediately, prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 15210831
• MDR Text Key: 298584256
• Report Number: 1119421-2022-01762
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652250481
• UDI-Public: 00380652250481
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.230
• Device Lot Number: 15294922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR