Model Number ZKB00 |
Device Problems
Material Puncture/Hole (1504); Device Damaged by Another Device (2915)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
|
Event Date 11/08/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
All pertinent information available to abbott medical optics has been submitted.
|
|
Event Description
|
It was reported that an intraocular lens (iol) was punctured by the inserter during insertion into the eye.Information for inserter or cartridge was not provided.No further information was provided.
|
|
Manufacturer Narrative
|
Additional info: additional information was received and it was learnt that the intraocular lens (iol) was fully inserted into the patient's eye and it was removed and replaced, during the same surgical procedure.The inserter and cartridge model and lot number were also provided.Concomitant medical products has been updated: cartridge 1mtec30, lot cb36700; injector dk7796, lot 146.All pertinent information available to abbott medical optics has been submitted.
|
|
Manufacturer Narrative
|
Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and 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 similar complaints for this order number have been received.Labeling review: the directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.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
|