MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PC VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number BL2282

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Loss of Vision (2139)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

The service engineer checked the logfiles which showed error code (cpx05) indicating the air pressure output is lower than commanded.The service engineer informed the staff of the meaning of the error code and verified how the accessories were set up, no issues were found.The firmware of fcib and footswitch were reset.The iop pump was stable with no leakage found.All the final tests were successfully passed and the system was certified ready for a clinical use.The device history record 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.A definitive root cause has not been determined.The investigation is ongoing.

Event Description

The user facility in (b)(6) reported an interruption of the infustion and instability in the posterior chamber during peripheral vitrectomy.An intraoperative expulsive hemorrhage of the right eye occurred as a result of significant unusual intraoperative intraocular pressure changes.The procedure was discontinued.Surgical intervention may be needed to evacuate the hematoma.The patient was kept at the hospital and put on a painkiller.The patient has lost functional use of the eye.

Manufacturer Narrative

Fields were corrected to "yes".

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman; rochester NY 14609
• MDR Report Key: 8532889
• MDR Text Key: 142537357
• Report Number: 0001920664-2019-00076
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL2282
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: D10, H3
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 72 YR