MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B POSTERIOR ELITE W WF; UNIT PHACOEMULSIFICATION

Model Number SE5425WVB

Device Problem Failure to Infuse (2340)

Patient Problem Intraocular Pressure Decreased (4468)

Event Date 12/02/2022

Event Type  Injury  

Manufacturer Narrative

This investigation is on going.

Event Description

The user facility reported loss of pressure in the patient's eye.To stabilize the chamber pressure was increased from 35 to 63 and had to reformulate the eye with air.The patient's incision was not enlarged, no suture, nor additional anesthesia was required.There was probably a delay of about 30 minutes to manually infuse sterile air and manually push through the line.The product was discarded on site, and no lot number recorded.

Manufacturer Narrative

Customer discarded product so unable to investigate further for reported complaint.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: 25G BI-B POSTERIOR ELITE W WF
• Type of Device: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 16095692
• MDR Text Key: 306624962
• Report Number: 0001920664-2023-00001
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SE5425WVB
• Device Catalogue Number: SE5425WVB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Treatment: STELLARIS UNIT.
• Patient Outcome(s): Other