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

Model Number AU00T0

Device Problems Failure to Unfold or Unwrap (1669); Defective Component (2292)

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

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the device with the lens was returned loose in the carton.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger has advanced beyond mid-nozzle.The lens was advanced to the fill line.The plunger has torn through the trailing optic material.The trailing haptic was broken at the gusset area and was extended into the optic fold.The leading haptic was in an extended position in the device tip.The leading distal haptic tip was broken and not returned.The nozzle was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was used.The root cause cannot be determined for the reported event.The lens was advanced to the fill line and torn by the plunger.Haptic damage was also observed.A qualified viscoelastic was indicated.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported during a cataract surgery with an intraocular lens (iol) implantation, the lens "wouldn't unfold; defective".There was patient contact.The procedure was completed.Additional information was provided indicating that there was no patient harm.

• 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 ; 8175514979
• MDR Report Key: 11301760
• MDR Text Key: 232344994
• Report Number: 1119421-2021-00261
• Device Sequence Number: 1
• Product Code: KYB
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: AU00T0
• Device Lot Number: 15067228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR