MAUDE Adverse Event Report: BAUSCH + LOMB 25 GA COMBINED PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5325WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.
Event or Problem Description
The user facility in japan reported the inner needle of the cutter sometimes was stuck in the open position and could not cut.Aspiration continued while the cutter stopped.It was replaced with a stand alone cutter(bl5625).No patient injury reported.
Additional Manufacturer Narrative
Evaluation completed.One 25ga vitrectomy cutter was returned in a plastic bag along with a bl5325wv pack label from lot v8181 was returned.The expiration date on the label is 2018-03-25.The tip protector was not returned.The needle was not bent.The port window was in the opened position.There was dried solution visible in the tubing.The back cap was aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no defects were found.A functional test was performed using a stellaris pc system.The cutter did not cut.The inner needle gradually stopped retracting from the port window until it was blocking the port.This prevents cutting and aspiration.Although this cutter did not stop and remain in the opened position, it is defective and cannot function properly.

• Brand Name: 25 GA COMBINED PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6849048
• Report Number: 0001920664-2017-00272
• Device Sequence Number: 13853152
• Product Code: HQC
• UDI-Device Identifier: 00757770058655
• UDI-Public: (01)00757770058655(17)180325
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

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: No Information
• Device Expiration Date: 03/25/2018
• Device Model Number: BL5325WV
• Device Catalogue Number: BL5325WV
• Device Lot Number: V8181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1