MAUDE Adverse Event Report: BAUSCH + LOMB POWER SUPPLY MODULE; UNIT, PHACOFRAGMENTATION

Model Number BL2351

Device Problem Unexpected Shutdown (4019)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

A user facility in france reported that the system shutdown during use.There was no patient impact reported.

Manufacturer Narrative

The module was returned and evaluated.We were unable to reproduce the reported problem.A review of the device history record found no nonconformities or anomalies related to this complaint.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The initial report was submitted on (b)(6) 2024 under incorrect cfn/fei/hcfa id ((b)(6)) - core id (b)(4).Resubmitting initial report under correct cfn/fei/hcfa id ((b)(6)).

• Brand Name: POWER SUPPLY MODULE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: juli moore ; st. louis, MO ; 6362263220
• MDR Report Key: 19120137
• MDR Text Key: 341022340
• Report Number: 0001920664-2024-00054
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770524532
• UDI-Public: (01)00757770524532(11)190717
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2024

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 Operator: Health Professional
• Device Model Number: BL2351
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1