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

Model Number AU00T0

Device Problem Failure to Fold (1255)

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

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

The device with the lens was returned loose in 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 fully advanced at the tip and has underrode the lens.The lens was torn with a majority of the intraocular lens (iol) returned outside the device.The trailing portion of lens was inside the device tip, crushed on top of the plunger.The trailing haptic was misfolded, looped around the plunger tip underneath the lens.An aneurysm was observed on the posterior of nozzle tip.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.All product and batch history records are quality reviewed prior to product release.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause cannot be determined for the reported complaint.A plunger underride was observed in the nozzle tip.The lens was torn into pieces and the trailing haptic was misfolded, looped around the plunger tip.It is unknown if a qualified viscoelastic was used.There have been no other complaints in the lot.The manufacturer internal reference number is: (b)(4).

Event Description

A non-health professional reported that during an intraocular lens (iol) implant surgery, it was stated that, intraocular lens was not folding correctly.No further information is expected.

• 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: 13062869
• MDR Text Key: 282774634
• Report Number: 1119421-2021-02442
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394741
• UDI-Public: 00380652394741
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/22/2021

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 Expiration Date: 06/07/2024
• Device Model Number: AU00T0
• Device Lot Number: 15214151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female