MAUDE Adverse Event Report: BAUSCH + LOMB MICROFLOW PHACO NDL 30DEG 6/BX; PHACO NEEDLE

Model Number DP8230

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2017

Event Type  malfunction  

Event Description

The user facility in thailand reported the microflow needle left some debris after the surgery in the patient eyes.Additional information: some particulate was removed from the patient¿s eye but some was not because it was stuck to the wound.There was no medical intervention required.The patient is currently able to go home after surgery for a few days and has no affect.

• Brand Name: MICROFLOW PHACO NDL 30DEG 6/BX
• Type of Device: PHACO NEEDLE
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MN 63122 ; 636226-322
• MDR Report Key: 6875818
• MDR Text Key: 86632210
• Report Number: 0001920664-2017-00288
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K954340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: DP8230
• Device Lot Number: 10621311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1