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

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	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the reported event was requested however to date it was not received.We are unable to confirm the reported event.The lot/device manufacturing records were reviewed and found acceptable.
Event or Problem Description
A report received from a user facility in the (b)(6) stated that the cutter stopped working after cutting the vitreous.The cutter was replaced and the procedure was completed without any injury or consequences to the patient.
Additional Manufacturer Narrative
Two 23ga vit cutters were returned in an opened bl5523wv pack from lot v9016.Visual examination found the tip protectors missing in both cutters however the needles were not bent.The port window was in the opened positions and the back cap was aligned correctly with the vent hole in the side of both cutters body.Dried solution was visible in the tubing.The connectors in both cutters were inspected and no defects were found.A functional test was performed using a stellaris pc system.One cutter had a good clean cuts throughout the various cut rates and it aspirated as intended.The second cutter was also functionally tested using the stellaris pc system and found to be clogged.The inner needle was bound up and had reduced aspiration.The cutter needle was soaked in hot water for 1 full minute and then re-tested.The needle broke free and had good clean cuts throughout the various cut rates and had good aspiration.Due to the evidence of use, the origin of the blockage cannot be determined.

• Brand Name: 23 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: 6820334
• Report Number: 0001920664-2017-00270
• Device Sequence Number: 65490
• Product Code: HQC
• UDI-Device Identifier: 00757770058549
• UDI-Public: (01)00757770058549(17)180911
• 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: 09/11/2018
• Device Model Number: BL5523WV
• Device Catalogue Number: BL5523WV
• Device Lot Number: V9016
• 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