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

Model Number	BL5525WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot/device manufacturing records were reviewed and found to be acceptable.
Event or Problem Description
A report from a user facility in the united kingdom stated that the cutter stopped working.The cutter was restarted but failed again.The cutter was replaced and the procedure was completed without any patient injury.
Additional Manufacturer Narrative
Two 25ga vit cutters were returned in a bl5525wv pack from lot v8993.Visual inspection found fluid in the tubing, in the iv spike drip chamber and in the collection cassette.Both cutters were visually inspected.One needle was found bent in one of the cutters, dried solution was visible in the tubing and the port window was the opened position with the back cap correctly aligned with the vent hole in the side of both cutters'' body.The connectors in each cutter were inspected and no defects were found.A functional test was performed using a stellaris pc system.Even though one of the needles was bent, both cutters had good clean cuts throughout the various cut rates and aspirated as they should.In addition, the collection cassette was functionally tested using the stellaris pc system.The cassette was captured and recognized by the system.The whole assembly passed the self-vacuum test, primed, irrigated and aspirated as intended.The reported failure could not be confirmed.

• Brand Name: 25 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI &WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6820402
• Report Number: 0001920664-2017-00271
• Device Sequence Number: 1431184
• Product Code: HQC
• UDI-Device Identifier: 00757770058631
• UDI-Public: (01)00757770058631(17)180904
• 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): 07/26/2017

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: 09/04/2018
• Device Model Number: BL5525WV
• Device Catalogue Number: BL5525WV
• Device Lot Number: V8993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 08/25/2017
• 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