MAUDE Adverse Event Report: BAUSCH + LOMB 20GA ANTERIOR VITRECTOMY CUTTER; UNIT, PHACOFRAGMENTATION

Model Number BL5612

Device Problem Particulates (1451)

Patient Problem No Information (3190)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.

Event Description

The user facility in (b)(6) reported that when the surgeon put the metal cannula on the vitrectome, black particles came out of the end of the vitrectome.There was no aspiration or cutting.The catheter was changed.Additional information has been requested.

Manufacturer Narrative

The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.This investigation is complete.

• Brand Name: 20GA ANTERIOR VITRECTOMY CUTTER
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 9564372
• MDR Text Key: 174289392
• Report Number: 0001920664-2020-00007
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2020
• Device Model Number: BL5612
• Device Lot Number: W3808
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1