Model Number SN6AT4 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
Blurred Vision (2137)
|
Event Date 04/22/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).
|
|
Event Description
|
A facility representative reported that three weeks following an intraocular lens (iol) implant procedure, the iol was exchanged for another lens due to blurred vision.The clinical reason given for the explant was "mechanical complication of iol." additional information has been requested.
|
|
Manufacturer Narrative
|
The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
Additional information was received indicating the toric marker was not lined up where it was planned to be, and the patient ending up with residual astigmatism.
|
|
Search Alerts/Recalls
|