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

Model Number BL2114

Device Problem Increase in Pressure (1491)

Patient Problem Capsular Bag Tear (2639)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

The system was evaluated at the user facility site.The system was checked with a cassette and handpiece, no issue was found.The customer discarded the procedure pack used during the procedure.The ccd camera was replaced after field service reviewed the system log files, and due to the error messages the user facility reported.The device history record was reviewed, and no anomalies were found.The investigation is ongoing.

Event Description

The user facility in (b)(6) reported during the irrigation/aspiration step, an audio message said ''purge finished'', and the pressure went up to 520mmhg.The patient received an implant, there was a chamber puncture without vitreous infiltration into the anterior chamber.The procedure was extended by more than 30 minutes.General anesthesia was not given since the patient has parkinsons, however twice the initially planned dose of ketamine, supplenta and midazolan were given.The patient was observed post op, no visual acuity done, however, the patient indicated they can see better.The user facility reported receiving error messages from the system of, ''the cassette vacuum check is in progress," "please insert the cassette," and ''the fluid level sensor could not be read,'' but did not stop surgery.The surgeon's concern is that although the implant is in place, a haptic is behind the posterior capsule (there is no vitreous rising because the hyaloid is not broken), and the other haptic is positioned in the capsular bag.The risk is that the hyaloid will tear, and the implant will fall into the posterior segment.The patient was seen on post op day 1 and day 8, no further treatment needed except regular monitoring by surgeon.The hyaloid did not break, and no vitreous is coming up.One haptic of the implant remains in the bag and the distal haptic behind the posterior capsule.

Manufacturer Narrative

Based on all available information, no causal factors can be determined and no conclusion can be drawn.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No further investigation or corrective action necessary.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 10757089
• MDR Text Key: 214326732
• Report Number: 0001920664-2020-00137
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL2114
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STELLARIS SYSTEM AND ACCESSORIES