ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR
|
Back to Search Results |
|
Model Number AU00T0 |
Device Problem
Failure to Deliver (2338)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/20/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 was observed in the device.The plunger has been advanced to mid-loading area.The plunger was engaged to the trailing haptic edge, prior to the optic.The optic was advanced partially into the nozzle entry area.The right side of the optic was tilted upward.The trailing haptic was misfolded underneath the right side of the optic inside the loading area.The leading haptic was ahead of the optic.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 trailing haptic was misfolded and advanced under the optic inside the loading area.It is unknown if a qualified viscoelastic was used.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) implant procedure, there was a defective cartridge that would not advance.There was patient contact and the procedure was completed.Additional information was requested.
|
|
Search Alerts/Recalls
|
|
|