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

Model Number AU00T0

Device Problems Break (1069); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

A sample product 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 is one other complaint in the lot.(b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure the plunger went right through the middle of the lens causing damage to the lens.There was no patient contact and another lens was implanted instead.Additional information was requested.

Manufacturer Narrative

The device with the lens was returned.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been advanced over the lens to mid-nozzle.The lens is still partially in the loading area under the plunger.The trailing haptic is folded in on the optic.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.A qualified viscoelastic was indicated.The root cause for the plunger override could not be determined.The plunger was advanced over the lens, the plunger was not advanced through the lens.The plunger position advanced to mid-nozzle with the lens still in the loading area may indicate the plunger was advanced too rapidly.Additional information was provided in d.10., h.3., h.6.And h.10.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 8595300
• MDR Text Key: 144683714
• Report Number: 1119421-2019-00638
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: AU00T0
• Device Lot Number: 12621420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VISCOAT