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); Scratched Material (3020)

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

Event Date 10/04/2022

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 nurse reported during the intraocular lens implantation on inserting the lens, the lens delivery system did not offer any resistance and the surgeon was shocked as to how quickly the lens came out of the injector.There appeared to be no damage to the patient, however on the lens opening up, there was a scratch on the lens which was in the center of the patients' vision.The surgeon felt this could not be left in place as it would have affected the patient immensely after surgery.The lens was cut in half inside the eye, removed, and replaced.Although it did come in to contact with the patient, no harm was caused to the patient, despite a longer surgery time.The operation was completed successfully.Additional information has been requested.

Manufacturer Narrative

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.The ifu instructs: 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.The product has not been received to evaluate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Only the used device was returned in a bag.The plunger lock and lens stop were removed.Viscoelastic was observed in the device.The plunger retracted toward mid-nozzle.The posterior right side of the nozzle tip has a large, wide aneurysm.The aneurysm began beyond the wound guard.The aneurysm enlarged and the device material folded within this damaged area.Heavy stress lines were also observed at the tip.The lens was not returned for an evaluation of damage.A non-qualified viscoelastic was indicated.Nozzle tip damage was observed.The tip has a large, wide aneurysm, which has folded the device material within the damaged area.The aneurysm was noted on the posterior right side beyond the wound guard with heavy stress.This damage would indicate the lens/plunger were not in an acceptable position for advancement.The instructions for use (ifu) instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a negative outcome.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: 15742013
• MDR Text Key: 307264109
• Report Number: 1119421-2022-02366
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652395373
• UDI-Public: 00380652395373
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2023

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: ACU0T0
• Device Lot Number: 15372282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 12/02/2022; 01/13/2023
• Supplement Dates FDA Received: 12/27/2022; 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEALON.
• Patient Age: 73 YR
• Patient Sex: Male