MAUDE Adverse Event Report: ALCON LENSX SOFT FIT PATIENT INTERFACE; UNIT, PHACOFRAGMENTATION

Model Number 300047917

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

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

Event Date 02/21/2023

Event Type  malfunction  

Event Description

Lensx softfit pi tubing came out/unloose and caused the suction not to hold for the procedure.

• Brand Name: LENSX SOFT FIT PATIENT INTERFACE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON
• MDR Report Key: 16447406
• MDR Text Key: 310379585
• Report Number: MW5115256
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300047917
• Device Lot Number: 150EYH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1