MAUDE Adverse Event Report: BAUSCH + LOMB VACUUM PHACO PACK WITH 2.2 MM SLEEVE; UNIT, PHACOFRAGMENTATION

Model Number	BLV3220000
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reports that the phaco sleeve has three holes in it and one of the holes was not punched and a part of the green sleeve and got into the anterior chamber.The doctor was able to aspirate it out.This happened twice on two separate patients on the same day.The products were disposed of.There was no medical intervention/treatment required.
Additional Manufacturer Narrative
The device was discarded and is not available for evaluation.The manufacturing and sterilization records were reviewed and found to be acceptable.The reported particle is not available for return so we are unable to investigate further for root cause.Review of the device history record shows product was properly made and met all release requirements.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 was deemed necessary.The investigation is complete.
Additional Manufacturer Narrative
Udi related data quality updates only.The udi is being corrected due to a typographical error in the udi-di.

• Brand Name: VACUUM PHACO PACK WITH 2.2 MM SLEEVE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 18365213
• Report Number: 0001920664-2023-70129
• Device Sequence Number: 12789359
• Product Code: HQC
• UDI-Device Identifier: 00757770058402
• UDI-Public: (01)00757770058402(17)250206(10)X4910
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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: 02/06/2025
• Device Model Number: BLV3220000
• Device Lot Number: X4910
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 10/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• 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 SYSTEM AND ACCESSORIES.
• Patient Sex: Unknown