Model Number CC60WF |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Manufacturer Narrative
|
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
A physician reported following the intraocular lens implantation, occasionally get some posterior capsule opacification (pco) where it appears the epithelial cells migrate across the lens and connect a bridge across the capsulotomy, but is not visually significant and easily taken care of at the time of yttrium aluminium garnet for pco.Additional information has been requested.
|
|
Manufacturer Narrative
|
Correction information provided in d.3.And g.9.Manufacturing site updated manufacturer report number corrected and reported under the manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|