MAUDE Adverse Event Report: BAUSCH + LOMB LASEREDGE OPHTHALMIC KNIFE; KNIFE, OPHTHALMIC

Model Number E7600

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

The device used during the reported event was disposed of by the user at the facility.The particle removed from the patient's eye was lost within the aspiration cannula.The lot number of the knife used in the event was not provided therefore the manufacturing records could not be reviewed.Photographs were taken during the event, however, the surgeon has declined to provide them.We are unable to confirm the source of the fragment or the cause of the event.

Event Description

A report received from a user facility in the (b)(6) indicated a fragment of metal was observed in the anterior chamber of the eye.The fragment had the appearance of the tip of the ophthalmic knife.The surgeon also observed particles with a metallic appearance in the incision.The fragment was removed from the eye with no injury to the patient.

• Brand Name: LASEREDGE OPHTHALMIC KNIFE
• Type of Device: KNIFE, OPHTHALMIC
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 7306709
• MDR Text Key: 101377370
• Report Number: 0001920664-2018-00024
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E7600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• 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