MAUDE Adverse Event Report: BAUSCH + LOMB PHACO ACCESSORY PACK; UNIT PHACOFRAGMENTATION

Model Number DP5501

Device Problem Particulates (1451)

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

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

Product and reported material were discarded so unable to investigate for root cause.The sterilization and lot history records 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.Report 1 of 3, see related medwatch report numbers: 0001920664-2022-00049, 0001920664-2022-00050.

Event Description

The user facility in (b)(6) reported when the surgeon inserted the phaco handpiece into the eye and started phacoemulsification, a white soft material flowed out from the left irrigating port.There was no effect on the patient.The surgery proceed as per normal, and completed with no complication.Post operative the patient seemed fine.No complication, no complaint from patient or doctor.

• Brand Name: PHACO ACCESSORY PACK
• Type of Device: UNIT PHACOFRAGMENTATION
• 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
• MDR Report Key: 14136978
• MDR Text Key: 289465184
• Report Number: 0001920664-2022-00048
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K961831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DP5501
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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.