ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR
|
Back to Search Results |
|
Model Number III |
Device Problems
Device Slipped (1584); Scratched Material (3020)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/21/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is in progress.A sample is expected, but has not been received at the investigation facility at this time.Based on the preliminary investigation findings, there has been no change in criticality for this complaint.No lot number was identified with this complaint; therefore, a lot history review could not be conducted.A root cause has not been identified.The root cause will be reassessed upon completing the investigation.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
A facility representative reported that during an intraocular lens (iol) implant procedure, the lens slid beneath the plunger, and as a result was scratched.In the surgeon's opinion, there was not an issue with the lens, but handling.There was no patient contact and the procedure was completed the same day.Additional information was requested.
|
|
Search Alerts/Recalls
|
|
|