MAUDE Adverse Event Report: BAUSCH + LOMB 1.8MM STABLE CHAMBER PHACO PACK WITH MICS NEEDLE; UNIT PHACOEMULSIFICATION

Model Number	BL5113
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been discarded and cannot be returned for evaluation.The investigation is ongoing.
Event or Problem Description
A user facility in france reported that during surgery there was a large amount of bubbles which lead to decreased visibility and the capsule to be ruptured.A follow up surgery was performed by a secondary retina specialist where they inserted the iol and surgery was extended by 30 minutes.
Additional Manufacturer Narrative
The root cause of this complaint could not be determined as the complaint unit was not available for analysis.Manufacturing and sterilization records for bl5114, lot x7596 were reviewed and found to be acceptable.Sterilization date: 27-feb-2025, expiration date: 11-jan-2028, manufacturing completed date: 20-feb-2025.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The investigation is complete.

• Brand Name: 1.8MM STABLE CHAMBER PHACO PACK WITH MICS NEEDLE
• Common Device Name: 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: amy frutiger ; 6362263089
• MDR Report Key: 23656838
• Report Number: 0001920664-2025-00125
• Device Sequence Number: 18655792
• Product Code: HQC
• UDI-Device Identifier: 10757770057235
• UDI-Public: (01)10757770057235(17)280315(10)X7919
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: BL5113
• Device Lot Number: X7919
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown