MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PC LASER MODULE; UNIT, PHACOFRAGMENTATION

Model Number	BL2271
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product return has been requested.The product has not been received.The certificate of compliance was reviewed and certifies that the module met all physical and functional requirements on the date of manufacture.The investigation is underway.
Event or Problem Description
A user facility in japan reports that during surgery a tear was found, which required laser treatment, but could not be performed.The next day, photocoagulation was performed using laser treatment.The patient outcome is "good".
Additional Manufacturer Narrative
The device was not returned for evaluation.We are unable to determine the root cause.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 was required.The investigation is complete.

• Brand Name: STELLARIS PC LASER MODULE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 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: 19918244
• Report Number: 0001920664-2024-00099
• Device Sequence Number: 8095111
• Product Code: HQC
• UDI-Device Identifier: 00757770524525
• UDI-Public: (01)00757770524525(11)210309
• Combination Product (Y/N): N
• 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): 07/08/2024

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: BL2271
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown