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

Model Number AU00T0

Device Problem Unintended Ejection (1234)

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

Event Date 11/14/2022

Event Type  malfunction  

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).

Event Description

A non-health care professional reported during the intraocular lens implantation the lens was faulty.Additional information has been requested and received and i was further clarified that lens was caught up in the incision and won¿t move forward when he is pushing the injector.There was patient contact and no harm to the patient.The surgery was completed on the same day.

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6., and h.10.The device with the lens was returned loose in the carton.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced over the trailing optic edge.The lens was advanced to the fill line.The trailing haptic was tucked in the optic fold.The leading haptic was extended.The nozzle was removed and cleaned for further evaluation.The lens was removed with cleaning.Top coat dye stain testing was conducted with acceptable results.It is unknown if a qualified viscoelastic was used.The root cause for the delivery issue could not be determined.A plunger underride occurred.The lens was still in the device.This was not an improper delivery.The device may have been placed into the incision and then the lens did not deploy due to the plunger underride.Top coat dye stain testing was conducted with acceptable results.It is unknown if a qualified viscoelastic was used.The instructions for use (ifu) instructs: during device preparation and implantation of the lens with the 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.Plunger underride may occur: ¿ due to rapid advancement faster than the dfu recommended rate.¿ due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.¿ 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.¿ if the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: INTRAOCULAR LENS
• 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: 15994907
• MDR Text Key: 305815969
• Report Number: 1119421-2022-02678
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652394819
• UDI-Public: 00380652394819
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: 15336933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROVISC.
• Patient Sex: Female