MAUDE Adverse Event Report: BAUSCH + LOMB 23 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI &WF; UNIT, PHACOEMULSIFICATION

Model Number	BL5523WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device used in the reported event was not received.The review of the lot/device manufacturing records did not find any anomalies or discrepancies related to the reported event.
Event or Problem Description
A report from a facility in the (b)(4) stated that the vitrectomy cutter was not cutting properly and it was causing traction.The cutter was replaced and the procedure was completed without any injury or consequences to the patient.
Additional Manufacturer Narrative
One 23ga cutter was returned inside a pouch with a piece of a bl5523wv pack label from lot v8895 taped on it.Visual examination found the tip protector missing and the needle bent.Dried solution is visible in the tubing.The port window is in the opened position and the back cap is 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 stopped cutting almost immediately, the inner needle is binding up and stops at the half center port position allowing the vacuum to continue.The cut is not cutting however it should be noted that a bent needle could contribute to the poor cutting performance.The cause of the bent needle cannot be determined.

• Brand Name: 23 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI &WF
• Common Device Name: UNIT, PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6837621
• Report Number: 0001920664-2017-00274
• Device Sequence Number: 13484065
• Product Code: HQC
• UDI-Device Identifier: 00757770058549
• UDI-Public: (01)00757770058549(17)180814
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2017

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: Health Professional
• Device Expiration Date: 08/14/2018
• Device Model Number: BL5523WV
• Device Catalogue Number: BL5523WV
• Device Lot Number: V8895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1