MAUDE Adverse Event Report: BAUSCH + LOMB PHACO ACCESSARY PACK 2.4MM SLEEVE; UNIT, PHACOFRAGMENTATION

Model Number	BL3124S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in australia reported that after the nucleus had been extracted during cataract surgery with a 2.0 tip and 2.4 sleeve, when the nurse removed the phaco handpiece from the eye to swap to irrigation/aspiration, part of the sleeve tore off and remained in the eye.The particle was able to removed and the procedure was successful with no impact to the patient.Staff noted the sleeve may have had a micro-tear prior to commencing surgery that was undetected.
Additional Manufacturer Narrative
The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.
Additional Manufacturer Narrative
The product was evaluated by the vendor.The results state, "failure analysis results: two broken pieces of the sleeve were returned.Visual inspection confirmed that tip of the sleeve was broken off from the shaft, and particulates were seen on the sleeve.Bhr review shows no abnormalities being identified.Results of evaluation: this complaint is filed as ¿reported issue confirmed¿ since the sleeve tip was confirmed broken off from the shaft.".
Additional Manufacturer Narrative
The product evaluation has been completed.One opened (b)(6) pouch from lot x8479 was returned.The expiration date on the label is 2030-jul-19.The mist-yellow irrigation sleeve is inside of a plastic specimen cup.Upon opening the cup, a strong chemical odor was noticed.The source of the odor is unknown.Visual inspection found the assembly is dirty with particulates and an unknown solution visible all over.The tip and part of the shaft of the sleeve have been torn off.Due to evidence of use, the cause of the torn shaft cannot be determined.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.

• Brand Name: PHACO ACCESSARY PACK 2.4MM SLEEVE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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 ; 6362263089
• MDR Report Key: 24591490
• Report Number: 0001920664-2026-00024
• Device Sequence Number: 9593885
• Product Code: HQC
• UDI-Device Identifier: 00757770059614
• UDI-Public: (01)00757770059614(17)300719(10)X8479
• Combination Product (Y/N): N
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BL3124S
• Device Lot Number: X8479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 04/03/2026; 05/07/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/23/2026; 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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
• Patient Sex: Unknown