MAUDE Adverse Event Report: BAUSCH + LOMB, INC. STELLARIS ELITE FOOT CONTROL; UNIT, PHACOFRAGMENTATION

Model Number	BL2394
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record was reviewed and showed that this module met specifications on the date of manufacture.The device was not received rather a technician was sent to evaluate the system on site.The evaluation revealed the base plate and laser switch were defective.The investigation is ongoing.
Event or Problem Description
A user facility in france reported that during a retinal detachment surgery at the end of the air vitrectomy the laser would not start.As they could not get the device to work they had to permanently infuse the eye with air.A second machine was used to complete the surgery.Surgery time was doubled, however no additional anesthesia was required.At the patients first check up their retina was flat under silicone and patient had a 5/10 acuity due to the cataract.
Additional Manufacturer Narrative
The product evaluation confirmed the failure mode.The most probable root cause is component issue.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 is required.The investigation is complete.

• Brand Name: STELLARIS ELITE FOOT CONTROL
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 4100 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 blvd; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 19778899
• Report Number: 0001920664-2024-00092
• Device Sequence Number: 20900196
• Product Code: HQC
• UDI-Device Identifier: 00757770524532
• UDI-Public: (01)00757770524532(11)230509
• Combination Product (Y/N): N
• PMA/510(K) Number: K170052
• 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): 05/27/2024

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: BL2394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown