Model Number SN60WF |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
Therapeutic Response, Decreased (2271)
|
Event Type
Injury
|
Manufacturer Narrative
|
A sample lens was not returned for analysis.The iol product history records were reviewed and documentation indicates the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
A purchaser reported that approximately 4 months after an intraocular lens (iol) was implanted, it was exchanged for a different model with a different power due to residual astigmatism indicated after initial lens implanted.Additional information was requested.
|
|
Manufacturer Narrative
|
The lens was returned in a small piece of sponge.The lens has been cut in half through the center of the optic.The lens was cleaned with lphse.Power and resolution testing was attempted.Exact focal length/resolution measurements could not be obtained due to the optic damage.However, the lens is within the 20.0 diopter range.Qualified associated product were indicated.The root cause for the reported refractive error could not be determined.Exact focal length/resolution measurements could not be obtained due to the optic damage.However, the lens is within the 20.0 diopter range.Information was provided that the event was related to residual astigmatism.This monofocal does not correct for astigmatism.This monofocal lens was replaced with a monofocal toric lens.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|