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	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is in transit for evaluation and the lot number has been requested but not received.The investigation is ongoing.
Event or Problem Description
A user facility in the united kingdom reported a piece of plastic entered the eye out of the phaco tip needle.The piece of plastic was retrieved from the eye and there was no patient impact.
Additional Manufacturer Narrative
The device lot number was requested, however was confirmed to be unavailable.The particle was returned and evaluated.Evaluation showed the particle was whiteish in color and hard to touch.It was approximately 1915 microns long by 1551 microns wide.The components of the device pack were not returned for evaluation.A review of the device history record could not be completed as a lot number could not be provided.The lot history, trend analysis, risk analysis and /or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information we are unable to determine the source of the particle.No corrective action required.

• Brand Name: PREMIUM VACUUM PHACO PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 16628402
• Report Number: 0001920664-2023-70025
• Device Sequence Number: 5268774
• Product Code: HQC
• UDI-Device Identifier: 20757770057010
• UDI-Public: (01)20757770057010
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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 Model Number: BL5110
• Device Catalogue Number: BL5110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 03/28/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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