|
Model Number BL5623 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/03/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The product was disposed of and therefore will not be returned for evaluation.Manufacturing and sterilization records were reviewed and found to be acceptable.The device history records for lot w7378 found that the lot was manufactured using specified materials and that all assembly, inspection, and packaging steps were performed according to procedure by trained personnel.Bausch & lomb performs 100% inspection prior to packaging, and documentation confirms that this inspection was completed for this lot.The investigation is ongoing.First pack - 0001920664-2021-00109.
|
|
Event Description
|
It was reported by the (b)(6) national medical device adverse events reporting system that during a vitrectomy surgery, the tip fractured.The patient was under local anesthesia.The tip was replaced with a new one, and the tip fractured again.The surgery was performed normally, and prolonged by a few minutes.There was no harm to the patient and the no additional anesthesia required.
|
|
Manufacturer Narrative
|
The product is not available for return so we were unable to investigate for the root cause.Review of complaint trends and device history record shows this lot was manufactured properly and met all release specifications.The most probable root cause is unknown and inconclusive.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is required.Should the product be received, further investigation will follow.The investigation is considered complete at this time.See related first pack - 0001920664-2021-00109.
|
|
Search Alerts/Recalls
|
|
|