ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION
|
Back to Search Results |
|
Catalog Number 8065751761 |
Device Problems
Failure to Prime (1492); No Flow (2991)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/06/2023 |
Event Type
malfunction
|
Event Description
|
A customer reported that before surgery while using an ophthalmic handpiece the balanced salt solution wasn't flowing, and became impossible to prime the handpiece.System message was displayed and the procedure was completed by replacing the handpiece with no patient impact.
|
|
Manufacturer Narrative
|
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
|
|
Manufacturer Narrative
|
The initial decision to report was incorrect resulting in the initial report being submitted in error.This event error 257, the bss wasn't flowing, prime error is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.No further reports will be scheduled under mfg report num.2028159-2023-00468.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|
|
|