MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number AU00T0

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2022

Event Type  malfunction  

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

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, there is a dent/scratch on the lens.Additional information has been requested and provided that damage lens removed and surgery was commenced using a new lens with same diopter.There was no patient harm.

Event Description

A nurse reported, that during an intraocular lens (iol) implant procedure.There is a dent/scratch on the lens, as the introducer jolted.

Manufacturer Narrative

A non-qualified viscoelastic was indicated.The root cause may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used in the device.Material properties of non-qualified ophthalmic viscoelastic devices (ovd) may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.The ifu instructs: during device preparation and implantation of the company lens iol with the company device 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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The used device and the lens were returned inside the opened carton.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to near mid-nozzle.There was no damage observed to the device.The plunger was removed to evaluate.There was no damage observed to the plunger.The plunger was reinserted with no problem found.The plunger was secure at the starting point.The lens was returned inside a small, thin, cylindrical tube with a screw top lid.Solution was observed on the lens.The optic appeared to be cut into two portions, typical of damage created to help facilitate the lens removal from the eye.The optic was torn at the edge extending into the anterior and posterior optic material.The anterior optic surface has scratches near the optic center.A non-qualified viscoelastic was indicated.The reported scratch damage on lens was observed.No damage was observed to the plunger or device.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was indicated.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH 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: 14377098
• MDR Text Key: 291613191
• Report Number: 1119421-2022-01009
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394727
• UDI-Public: 00380652394727
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2023

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: AU00T0
• Device Lot Number: 15307762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 06/29/2022; 01/19/2023
• Supplement Dates FDA Received: 07/27/2022; 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEALON PRO - J&J