MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS FOOT CONTROL W/ BATTERY; UNIT, PHACOFRAGMENTATION

Model Number	BL2390
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Inflammation (1932); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned rather a field service technician was dispatched to evaluate the system on site.The system was found functioning to specification, and the reported problem was not reproducible.The review of the device history record review found that the system met specifications on the date of manufacture.The patient is doing well.The investigation is underway.
Event or Problem Description
A user facility in the united kingdom reported that they tried to use the foot pedal and had no response from it during segment removal.The operation was stopped and the patient was sent back to ward from theatre with only the capsulorohexis having been done and phaco not started.This caused some corneal inflammation.The patient was not left aphakic.After a 90 minute delay, when the system was working again the operation was completed the same afternoon.An additional top up of topical anesthesia was given.A follow up with the patient shows they are doing well with no concerns regarding visual outcome.
Additional Manufacturer Narrative
The root cause could not be determined, the field service engineer was not able to recreate fault.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 required.Health effect clinical code 1 removed 4582.Health effect impact code 2 removed 4633; added 4644.Health effect impact code 1 removed 2199.

• Brand Name: STELLARIS FOOT CONTROL W/ BATTERY
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 16899284
• Report Number: 0001920664-2023-70048
• Device Sequence Number: 5458897
• Product Code: HQC
• UDI-Device Identifier: 00757770497836
• UDI-Public: (01)00757770497836
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: BL2390
• Device Catalogue Number: BL1433
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female