MAUDE Adverse Event Report: BAUSCH + LOMB, INC 23 GA HIGH SPEED VITRECTOMY CUTTER; UNIT, PHACOFRAGMENTATION

Model Number	BL5623
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional 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.Second pack - 0001920664-2021-00110.
Event or Problem Description
It was reported by the (b)(6) 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.
Additional 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 second pack - 0001920664-2021-00110.

• Brand Name: 23 GA HIGH SPEED VITRECTOMY CUTTER
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 n goodman st; rochester NY 14609
• MDR Report Key: 12598566
• Report Number: 0001920664-2021-00109
• Device Sequence Number: 19631218
• Product Code: HQC
• UDI-Device Identifier: 20757770057911
• UDI-Public: (01)20757770057911(17)211118
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K010325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2021
• Device Model Number: BL5623
• Device Catalogue Number: BL5623
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR