MAUDE Adverse Event Report: BAUSCH + LOMB AIR INJECTION CANNULA 30 GA; HANDHELD SURGICAL INSTRUMENT

Model Number E0499 30

Device Problem Particulates (1451)

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

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

The instrument was visually inspected under a microscope.There is no evidence of material defect or manufacturing error.A particle test was conducted on the instrument resulting in no silver flecks found.Could not duplicate complaint issue.The device history was reviewed and found to meet manufacturing specification.

Event Description

It was reported when the doctor pushed on the cannula to release fluid silver flecks went in the patient's eye.The flecks were removed form the eye and the surgery was completed with no impact to the patient.

• Brand Name: AIR INJECTION CANNULA 30 GA
• Type of Device: HANDHELD SURGICAL INSTRUMENT
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122 ; 636226-322
• MDR Report Key: 6875808
• MDR Text Key: 86725049
• Report Number: 0001920664-2017-00289
• Device Sequence Number: 1
• Product Code: HNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/23/2017

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: E0499 30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1