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

Model Number ACU0T0

Device Problem Defective Device (2588)

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

Event Date 02/10/2022

Event Type  malfunction  

Manufacturer Narrative

The device with the lens was returned inside a large biohazard bag.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger has been advanced to mid-nozzle.The optic was folded.The trailing haptic was misfolded, looped across the plunger tip and extended backward along the right side of the plunger.The trailing haptic distal tip was oriented toward the loading area.The leading haptic was straight.Product history records were reviewed, and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The trailing haptic was misfolded, looped around the plunger tip.This was most likely interpreted as the reported complaint.The root cause for the misfolded trailing haptic cannot be determined.Haptic folding may be influenced by an intermittent plunger rate or if the operating room temperature is too high (> 23°c / 73° f).If the operating room temperature is too high lens folding consistency is negatively affected as the lens more adherent.This may inhibit lens advancement or contribute to incorrect haptic folding.No further information has been provided.If additional information becomes available, the file will be reopened and updated.There have been one other complaint reported in the lot.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, there was an error in the injector.Additional information was provided that there was a patient contact.There was no patient harm, the surgeon prognosis was good and patient was not hospitalized.No further information available.

• 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: 13950219
• MDR Text Key: 288198528
• Report Number: 1119421-2022-00636
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652395281
• UDI-Public: 00380652395281
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• 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: 15229150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUOVISC VISCOELASTIC SYSTEM
• Patient Age: 61 YR
• Patient Sex: Female