MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number ACU0T0

Device Problems Defective Device (2588); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2023

Event Type  malfunction  

Event Description

An other healthcare professional reported a faulty lens.Additional information has been requested.

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 device with the lens was returned.The plunger lock and lens stop had been removed.The plunger was oriented correctly.Inadequate viscoelastic was observed in the device.The plunger was advanced under the lens.The lens was advanced to the fill line.The lens was misfolded rotated to the right.The trailing haptic was misfolded, broken.The leading haptic was tucked in the optic fold.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.A plunger underride was observed.The root cause may be related to a failure to follow the instructions for use (ifu).There did not appear to be adequate viscoelastic in the device.It is unknown if a qualified viscoelastic product was used.The ifu instructs: fill the device until viscoelastic can be observed flowing to the line on the nozzle tip.This will require approximately 0.2 ml of viscoelastic.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to underride the lens.During device preparation and implantation of the company iol with the company preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.Top coat dye stain testing was conducted with acceptable results.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• 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: 17939489
• MDR Text Key: 325733288
• Report Number: 1119421-2023-01765
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652395137
• UDI-Public: 00380652395137
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ACU0T0
• Device Lot Number: 15521391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1