MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER LUXOR OPHTHALMIC MICROSCOPES; MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC

Model Number LX3

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A customer reported that during a cataract procedure, the microscope would not focus up or down.The case was aborted.The eye was filled with viscoelastic and the wound was closed.The patient was transported from operating room one to operating room three.The case was completed without further incident.

Manufacturer Narrative

The system was examined and the reported event was confirmed (via event log review).The focus clutch assembly was adjusted, which resolved the issue.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on february 14, 2018.Based on qa assessment, the product met specifications at the time of release.The root cause can be attributed to a non-conforming focus clutch assembly.(b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received from the customer reporting there was no postoperative complications.

• Brand Name: LUXOR OPHTHALMIC MICROSCOPES
• Type of Device: MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7521913
• MDR Text Key: 108507544
• Report Number: 2028159-2018-01023
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LX3
• Device Catalogue Number: 8065753062
• Other Device ID Number: 380657530625
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2018
• 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
• Patient Outcome(s): Required Intervention