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 Activation, Positioning or Separation Problem (2906)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

A sample device 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 have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) procedure, the plunger went over the iol during an intraocular lens procedure.The iol was replaced and the procedure was completed without patient harm.

Manufacturer Narrative

The device with the lens was returned.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Inadequate viscoelastic is observed in the device.The plunger has been advanced over the lens into the nozzle entry area.The lens is still in the loading area.The trailing haptic is folded in on the optic.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.A plunger override was observed.The root cause may be related to a failure to follow the directions for use.Inadequate viscoelastic was observed in the device.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 11375854
• MDR Text Key: 234754679
• Report Number: 1119421-2021-00417
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15068916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC