MAUDE Adverse Event Report: BAUSCH + LOMB 23G BI-B POSTERIOR ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number	SE5423WVB
Medical Device Problem Codes	Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vitreous Loss (2142)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is not available.Manufacturing and sterilization records were reviewed and found to be acceptable.This investigation is ongoing.
Event or Problem Description
It was reported by a user facility in spain that the vitreous was ruptured in the operating room.Additional information has been requested.
Additional Manufacturer Narrative
This complaint does not contain sufficient details to evaluate an alleged defect with this product.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.Correction to d4 (udi) from: (b)(4).

• Brand Name: 23G BI-B POSTERIOR ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 24193043
• Report Number: 0001920664-2026-00007
• Device Sequence Number: 7893818
• Product Code: HQC
• UDI-Device Identifier: 10757770059932
• UDI-Public: (01)10757770059932(17)280315(10)X7922
• Combination Product (Y/N): Y
• 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
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: SE5423WVB
• Device Lot Number: X7922
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown