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

Model Number LX3

Device Problems Break (1069); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A doctor of ophthalmology reported that a several times a system message was displayed on the screen regarding the footswitch not being fully charged and needing to be charged.The event occurred even after a night charging.They tried to connect the cable to the footswitch but they could not manage to get the black stopper out of the footswitch.The stopper broke while trying to get it out.Finally the stopper was taken out with a screwdriver and the footswitch was connected with a cable.Additionally, the head of the microscope was moving (was loose) when they tried to move the microscope up and down.The movement of the microscope up and down was also going very heavy and was making noise.No negative effect was reported for the patients.It is unknown when did the events occur.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the system was examined by a company representative who did not indicate finding any issues that would be associated with the reported event.However, the footswitch plug was replaced as a preventive measure.The system was tested and found to meet product specifications.The stand met specifications at the time of release.The root cause cannot be determined conclusively.(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: 5331522
• MDR Text Key: 35060063
• Report Number: 2028159-2015-10209
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LX3
• Device Catalogue Number: 8065752560
• Other Device ID Number: 1.02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2016
• Date Device Manufactured: 10/23/2014
• 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