MAUDE Adverse Event Report: BAUSCH + LOMB 23 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF; UNIT PHACOEMULSIFICATION

Model Number	BL5423WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned so we were unable to investigate further for root cause.Manufacturing and sterilization records for bl5423wv, lot x2274 were reviewed and found to be acceptable.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.
Event or Problem Description
The user facility in china reported a vitrectomy cutter was not cutting.
Additional Manufacturer Narrative
Two opened bl5423wv packs from lot x2274 were returned.The expiration dates on the labels is 2023-dec-16.The tip protectors were in place, as they should be.The needles were not bent.The port windows were in the opened position.There was no evidence of dried solution visible in the tubing.The cutters were clean and dry and did not appear to have been used.The back caps were aligned correctly with the vent holes in the sides of the cutter bodies.The connectors were inspected, and no damage was found.A functional test was performed using a stellaris pc system.The cutters had good clean cuts throughout the various cut rates and had good aspiration.These cutter performed as intended.This investigation is complete.
Additional Manufacturer Narrative
Correction: d4 udi number corrected.

• Brand Name: 23 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 18483588
• Report Number: 0001920664-2024-70009
• Device Sequence Number: 9128294
• Product Code: HQC
• UDI-Device Identifier: 00757770058556
• UDI-Public: (01)00757770058556(17)231226(10)X2274
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101325
• 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): 12/19/2023

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 Expiration Date: 12/26/2023
• Device Model Number: BL5423WV
• Device Lot Number: X2274
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; 10/04/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 04/25/2024; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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