MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number ACU0T0

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Patient Involvement (2645)

Event Date 09/22/2018

Event Type  malfunction  

Manufacturer Narrative

A sample product was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.Additional data was requested.(b)(4).

Event Description

A facility representative reported that when a preloaded injector with an intraocular lens (iol) was being primed for use, it was very stiff.The surgeon did not want to use the product due to concerns that it could have an improper delivery.There was no patient involved.Additional information was requested.

Manufacturer Narrative

The device was returned.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.No plunger, nozzle or tip damage observed.The lens was not returned.The nozzle was removed and cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The root cause for the reported event could not be determined.The report indicated the surgeon felt "stiffness" and stopped using the device.However, the device was returned and the lens had been delivered.No problems was found with the returned device.No plunger, nozzle or tip damage was observed.Viscoelastic was not provided.It is unknown if a qualified product 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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 7966961
• MDR Text Key: 123848913
• Report Number: 1119421-2018-01489
• 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,other
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: ACU0T0
• Device Lot Number: 12594568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1