Model Number SA60WF |
Device Problem
Structural Problem (2506)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/20/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Evaluation summary: the product was not returned for analysis.Based on the results from the product and batch history record, the product met release criteria.Root cause cannot be identified at this time.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
A customer reported a folding issue with an intraocular lens (iol).There was reported patient contact but no reported patient impact.Additional information was requested.
|
|
Manufacturer Narrative
|
The product was returned for analysis.Additional information: the lens was returned just past the loading area in a iii (d) cartridge.Inadequate viscoelastic is observed in the cartridge.The trailing haptic is extended back behind the lens.The leading haptic is folded back toward the optic.The cartridge has no evidence of being placed into a handpiece.The cartridge was cleaned for further evaluation.The lens was removed and placed in the lens case.Top coat dye stain testing was conducted with acceptable results.The root cause for the reported complaint appears to be related to a failure to follow the dfu.No viscoelastic was observed past the lens.The dfu instructs to fill the cartridge with viscoelastic before loading the lens.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage or delivery issues.Top coat dye stain testing was conducted with acceptable results.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|