Model Number SN60AT |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
Retinal Tear (2050)
|
Event Type
Injury
|
Manufacturer Narrative
|
The product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.No further information is expected as the consumer declined to provide the surgeons contact information.(b)(4).
|
|
Event Description
|
A consumer reported that following an intraocular lens (iol) implant procedure, the lens did not enhance her vision and a retinal tear occurred.The consumer declined to provide the surgeon's contact information; therefore, no further follow up was conducted.
|
|
Manufacturer Narrative
|
Evaluation summary: the product was not returned.The lot number was provided.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).
|
|
Search Alerts/Recalls
|