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

Model Number	BL5223W
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
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 (b)(4) reported the vitrectomy cutter had difficulty cutting.There was no impact to the patient.
Additional Manufacturer Narrative
Evaluation completed.One opened bl5223w pack from lot v8548 was returned.The expiration date on the label was 2018-06-16.The tip protector was not returned.The needle was not bent.The port window was in the opened position.There was fluid in the aspiration line.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 collection cassette was captured and recognized by the system.The assembly passed the self-vacuum test, primed, irrigated and aspirated as intended.In addition, the cutter had good clean cuts throughout the various cut rates and vacuumed, as it should.No defects were found.

• Brand Name: 23GA POSTERIOR PROCEDURAL PACK WITH WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6911599
• Report Number: 0001920664-2017-00292
• Device Sequence Number: 16331490
• Product Code: HQC
• UDI-Device Identifier: 20757770058086
• UDI-Public: (01)20757770058086(17)180616
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2017

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: Physician
• Device Expiration Date: 06/16/2018
• Device Model Number: BL5223W
• Device Lot Number: V8548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1