Model Number SN6AT5 |
Device Problem
Overcorrection (3006)
|
Patient Problem
Visual Impairment (2138)
|
Event Type
Injury
|
Manufacturer Narrative
|
Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and 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).
|
|
Event Description
|
A nurse reported that following an intraocular lens (iol) implant procedure, the patient experienced overcorrection and reported a vision issue.The lens was too strong and was exchanged for a different lens model and.5 diopter difference in lens power 2 months after initial implantation.Additional information was requested.
|
|
Manufacturer Narrative
|
Product evaluation: the iol was not returned for analysis.The root cause was determined to be a coincidental event related to patient condition.A malfunction has not been indicated or information provided that the lens was the cause of the event.Based on this information, the device did not cause/contribute to the event.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|