MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ULTRASOUND HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number BL3170

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Eye Injury (1845)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

The handpiece is not being returned for evaluation.The facility continues to use it without issues.The investigation is ongoing.

Event Description

A facility in (b)(6) reported that a corneal burn occurred while removing a hard cataract.Per the doctor, who wishes to remain anonymous, all went well and the handpiece continues to be used without any issues.

Manufacturer Narrative

Describe event or problem: additional information: the patients 1st eye: first eye was operated on earlier.Vision was lost.The vision of patient was about 6/36 post op¿ (for the first eye).It was no vision or legally blind.The patient did not have 6/6 vision but that was not the direct result of phaco or any wound burn.It was because ecce was performed.The patients 2nd eye: doctors had decided to convert from phaco to extra capsular cataract extraction.They were concerned as it was a hard cataract and the use of phaco extraction would require a high energy, which could cause a wound burn.The dhr has been reviewed and there are no anomalies.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 is necessary.The investigation is complete.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 8139247
• MDR Text Key: 129518969
• Report Number: 0001920664-2018-00167
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL3170
• Device Catalogue Number: BL3170
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1