MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ENGAUGE; UNIT, PHACOFRAGMENTATION

Model Number 8065751577

Device Problems Loose or Intermittent Connection (1371); Optical Problem (3001)

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

Event Date 04/13/2023

Event Type  malfunction  

Event Description

Light was leaking at connection plug to constellation, producing low light at hand piece.

• Brand Name: ENGAUGE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 17245908
• MDR Text Key: 318282421
• Report Number: 17245908
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2023

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 Operator: Health Professional
• Device Model Number: 8065751577
• Device Catalogue Number: 8065751577
• Device Lot Number: 25253665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7665 DA
• Patient Sex: Male