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

Model Number AU00T0

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The product has not returned.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.The root cause has not been identified.(b)(4).

Event Description

A physician reported the plunger of the preloaded intraocular lens (iol) passed through the iol when attempting to insert it into the eye.The tip of the plunger did not hit the lens and the lens could not be inserted into the eye.The surgery was completed with the use of another manufacturers iol.

Manufacturer Narrative

Product evaluation: the device with the lens was returned loose in the opened carton.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been advanced almost completely.The plunger tip is near the nozzle tip exit.The plunger has overridden the lens.The lens is still partially within the loading area.The leading haptic is ahead of the optic and positioned underneath the plunger.The trailing haptic is folded onto 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.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.Root cause: a plunger override was observed.The lens was still partially within the loading area.The plunger was advanced almost completely with the plunger tip located near the nozzle tip exit.A qualified viscoelastic was indicated.Due to the observed plunger override of the lens within the loading area, this may suggest the plunger was advanced faster than the recommended rate.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: 10556454
• MDR Text Key: 208317004
• Report Number: 1119421-2020-01284
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: AU00T0
• Device Lot Number: 12730002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 10/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC 0.85 OPHTH VISC SUB 1%