MAUDE Adverse Event Report: BAUSCH + LOMB STERILE ULTRASOUND MICRO-COAXIAL PHACO NEEDLE ANGLED; UNIT, PHACOFRAGMENTATION

Model Number BL3318AS

Device Problem Particulates (1451)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2023

Event Type  malfunction  

Event Description

It was reported by the user facility that microscopic pieces of rigid plastic entered through the tubing cassette, and the needle into the patient's eye during surgery.The doctor used forceps to pull the rigid piece out.The incision was not enlarged and no sutures were needed.No patient impact or injury reported.

Manufacturer Narrative

Manufacturing and sterilization records were reviewed and found to be acceptable.The product is not available for return.This investigation is on going.See related report 0001920664-2023-70032.

Manufacturer Narrative

Correction h6 type of investigation from 4114 to 4115.The product nor the particle was available for evaluation and no further information has been provided.Therefore, we are unable to investigate further for root cause.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is required.See related report 0001920664-2023-70032.

• Brand Name: STERILE ULTRASOUND MICRO-COAXIAL PHACO NEEDLE ANGLED
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 16674907
• MDR Text Key: 312763243
• Report Number: 0001920664-2023-70031
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770505630
• UDI-Public: (01)00757770505630(17)260106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL3318AS
• Device Lot Number: X3534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STELLARIS UNIT.