MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED STELLARIS PC WITH LASER; UNIT, PHACOFRAGMENTATION

Model Number BL 14304

Device Problem Failure to Transmit Record (1521)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/23/2020

Event Type  No Answer Provided  

Event Description

Bausch & lomb, stellaris pc with laser, functioned therapeutically, but did not record the number of intraocular burns administered.This occurred with (2) separate pts, on (2) separate days: (b)(6) 2020, (b)(6) 2020.Reported to bausch & lomb rep (b)(4).Ref mw5092535.Fda safety report id# (b)(4).

• Brand Name: STELLARIS PC WITH LASER
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 9632562
• MDR Text Key: 177023424
• Report Number: MW5092536
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Model Number: BL 14304
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1