MAUDE Adverse Event Report: BAUSCH + LOMB, INC. PREMIUM VACUUM PHACO PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5110
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility in the united kingdom reported that during cataract surgery bubbles occurred and obscured the surgeons view.This caused the phaco tip to touch the capsule bag and resulted in a rupture.An anterior vitrectomy was performed and surgery was increased by 15-30 minutes.No additional anesthesia was required.
Additional Manufacturer Narrative
The product is not available for evaluation as the customer discarded it on site.Although requested, the ¿lot number¿ was not provided, therefore the udi-pi is not available.The device history record review cannot be performed.The root cause of this complaint could not be determined as the complaint unit was not available for analysis at the time of this evaluation.The 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: PREMIUM VACUUM PHACO PACK
• 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; saint louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; saint louis, MO 63122 ; 6362263089
• MDR Report Key: 23359928
• Report Number: 0001920664-2025-00114
• Device Sequence Number: 8818325
• Product Code: HQC
• UDI-Device Identifier: 20757770057010
• UDI-Public: (01)20757770057010
• Combination Product (Y/N): N
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2025

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: BL5110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS SYSTEM AND ACCESSORIES.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown