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

Model Number LX3

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 11/18/2015

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.Additional information has been requested.(b)(4).

Event Description

A nurse assistant reported that the light bulb turned off and a system message was displayed during a cataract surgery with intraocular lens (iol) implant.The microscope stopped.The incision had been already made.Another back up microscope was installed to fix the issue.Because of the time taken to replace the microscope, the "patient's tightened" and the surgery could not be completed.The doctor decided to close the eye and operate on the following day.It is unknown if the operation of the next day was completed.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Evaluation summary.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5288630
• MDR Text Key: 33268042
• Report Number: 2028159-2015-09958
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nursing Assistant
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• 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: 8065752570
• Device Lot Number: ASKU
• Other Device ID Number: 1.02BLD20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• Date Device Manufactured: 06/23/2015
• 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): Other; Required Intervention
• Patient Age: 76 YR