MAUDE Adverse Event Report: BAUSCH + LOMB POSTERIOR VACUUM PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5523W
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has been requested however it has not yet been received.Manufacturing and sterilization records were reviewed and found to be acceptable.
Event or Problem Description
The vitrector stopped working during phaco-vitrectomy surgery.Another vitrector was used to complete the surgery.There was no injury and no medical intervention was required.
Additional Manufacturer Narrative
One bl5523w assembly from lot v9291 was received.The assembly was wadded and tangled up inside a small cardboard box.The vitrectomy cutter was on the bottom of the box.The tip protector was not returned.The needle is bent.There is dried solution visible in the tubing.The back cap is aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no damage was found.A functional test was performed using a stellaris pc system.The cutter did not cut.The inner needle was bound up and could not advance into the port or reach the cutting edge.The cutter does aspirate.A bent needle could contribute to poor cutting performance.Due to the evidence of use and the returned condition of the product, the cause of the bent needle cannot be determined.

• Brand Name: POSTERIOR VACUUM PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7258924
• Report Number: 0001920664-2018-00013
• Device Sequence Number: 2006473
• Product Code: HQC
• UDI-Device Identifier: 20757770058178
• UDI-Public: (01)20757770058178(17)181015
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: 10/15/2018
• Device Model Number: BL5523W
• Device Lot Number: V9291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1