MAUDE Adverse Event Report: BAUSCH + LOMB 23 GA. POSTERIOR WIDE-FIELD ELITE PACK; UNIT, PHACOFRAGMENTATION

Model Number	SE5423WVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during surgery the vitrectomy cutter was found to have a strange noise and was not cutting.Aspiration continued after it stopped cutting.The surgery was extended, but the delay time was not provided.There was no patient impact.
Additional Manufacturer Narrative
The product has been requested but not received.The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Additional Manufacturer Narrative
The product has been received, but not yet evaluated.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 ongoing.
Additional Manufacturer Narrative
The product evaluation has been completed.One opened se5423wvb from lot x6707 was returned.The expiration date on the label was 2027-aug-04.Visual inspection found the tubing and components wadded and tangled up inside the pack tray.There was fluid in the drip chamber, tubing, and fluid droplets visible in the collection cassette.Further inspection found the 23ga bi blade vit cutter loose in the pack tray without the tip protector in place.The tip protector was loose in the tray.The needle was bent.There were droplets of dried solution in the cutter tubing.Closer inspection of the vit cutter found the aspiration barbed connector on the back cap is cracked in various locations and was missing material at one of the cracked locations.The root cause could not be determined.The investigation is complete.

• Brand Name: 23 GA. POSTERIOR WIDE-FIELD ELITE PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; 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 blv; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 21893790
• Report Number: 0001920664-2025-00056
• Device Sequence Number: 18163315
• Product Code: HQC
• UDI-Device Identifier: 10757770059932
• UDI-Public: (01)10757770059932(17)270804
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2025

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: SE5423WVB
• Device Lot Number: X6707
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/16/2025; 06/12/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/11/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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
• Patient Sex: Unknown