Model Number EMERALDC30 |
Device Problems
Bent (1059); Positioning Failure (1158); Failure to Deliver (2338)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/10/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
Implant date: not applicable; the lens was not implanted in the patient¿s eye.Explant date: not applicable; the lens was not implanted in the patient¿s eye.Concomitant medical products: zcb0000205 lens, serial number: (b)(4).All pertinent information available to abbott medical optics has been submitted.
|
|
Event Description
|
It was reported that the cartridge was bent and the lens touched the patient铠eye.Additional information confirmed that the lens was not inserted in the eye.The lens was stuck in the cartridge.Reportedly, there was no incision enlargement, no vitrectomy performed and no patient injury.The patient is doing well.
|
|
Manufacturer Narrative
|
The emeraldc30 cartridge is not recommended for use with a zcb00 one (1) piece iol.The emeraldc30 cartridge is the recommended cartridge for three (3) piece iols.The cartridge was return to the manufacturing site.Visual inspection revealed residues of viscoelastic solution and the intraocular lens was observed stuck in cartridge.Also, heavy dent/distortions were observed on cartridge tip.The complaint reported was verified.However use error may have contributed to the reported issue.Labeling review: 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 was verified.All pertinent information available to abbott medical optics has been submitted.
|
|
Search Alerts/Recalls
|