MAUDE Adverse Event Report: BAUSCH + LOMB PREMIUM VACUUM PHACO PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5110
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product will not be returned as hospital policy does not allow return.The particle has been requested for analysis.Manufacturing and sterilization records for this device were reviewed and found to be acceptable.The investigation is underway.
Event or Problem Description
A user facility in the united kingdom reported that the surgeon noticed a small foreign body flush into anterior chamber at start of phaco.The object was removed.It was described as ¿white plastic¿, and translucent material.No patient injury.
Additional Manufacturer Narrative
Correction: section b2, e, country of origin is ireland rather than the united kingdom as originally reported.The particle cannot be returned due to shipping company restrictions so no further investigation into root cause is possible.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.The investigation is complete.
Event or Problem Description
A user facility in ireland.

• Brand Name: PREMIUM VACUUM PHACO PACK
• 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: 16702841
• Report Number: 0001920664-2023-70033
• Device Sequence Number: 3640835
• Product Code: HQC
• UDI-Device Identifier: 20757770057010
• UDI-Public: (01)20757770057010(17)251008(10)X2949
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 03/10/2023

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
• Device Expiration Date: 10/08/2025
• Device Model Number: BL5110
• Device Catalogue Number: BL5110
• Device Lot Number: X2949
• 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: 04/07/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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
• Patient Sex: Unknown