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 Failure to Deliver (2338)

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

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the slade goes past the iol.There was patient contact but no patient harm.The surgery was completed the same day.

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6., and h.10.The device with the lens was returned loose in a bag.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger has advanced into the nozzle area and has overrode the lens.The lens was located within the lens loading area.The trailing haptic was folded onto the optic along the left side of the plunger.The leading haptic was positioned underneath the plunger.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause cannot be determined for the reported event.The used device was evaluated.A plunger override was observed.The lens was in the lens loading area.The plunger override was most likely interpreted as the reported event.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.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: 11596601
• MDR Text Key: 243186647
• Report Number: 1119421-2021-00710
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652395274
• UDI-Public: 00380652395274
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15090967
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/30/2021
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1