MAUDE Adverse Event Report: BAUSCH + LOMB MICS 2.0 SU NEEDLE; UNIT PHACOEMULSIFICATION

Model Number	BL3420S
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.The root cause of this complaint could not be determined as the complaint unit was not available for analysis.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.Related to 1920664-2025-00135.
Event or Problem Description
The user facility reported a wound burn at the main incision port during sculpt where 1x 10-0 vicryl was used to close.Bl3420s is the phaco tip and was disposed and isn¿t available for return.The doctor stated, it could have been a clogged tip but was not certain.

• Brand Name: MICS 2.0 SU NEEDLE
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 23980960
• Report Number: 0001920664-2025-00134
• Device Sequence Number: 14593890
• Product Code: HQC
• UDI-Device Identifier: 10757770058713
• UDI-Public: (01)10757770058713(17)280809(10)X8584
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: BL3420S
• Device Lot Number: X8584
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT AND ULTRASOUND HANDPIECE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown