Model Number PCB00 |
Device Problem
Delivery System Failure (2905)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/31/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
If implanted, give date: not applicable as the lens was not implanted.If explanted, give date: not applicable as the lens was not implanted and therefore not explanted.All pertinent information available to abbott medical optics has been submitted.
|
|
Event Description
|
It was reported that a preloaded delivery system, model pcb00, would not deliver the intraocular lens (iol).Reportedly the tip of lens was in the patient's eye when the issue occurred.Additional information was received and it was learnt that there was no incision enlargement, no suture and no vitrectomy was performed.The procedure was completed successfully with a backup lens.The patient was reported being fine.No further information was provided.
|
|
Manufacturer Narrative
|
Device available for evaluation? yes.Returned to manufacturer on: 12/07/2016.Device returned to manufacturer? yes.Device evaluation: the preloaded delivery system was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed a small amount of viscoelastic residues at the cartridge tube/tip.The intraocular lens (iol) was observed stuck at the cartridge tube.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.
|
|
Search Alerts/Recalls
|