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

Model Number LX3

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 12/09/2015

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 surgeon reported that during a cataract surgery the light of the microscope suddenly went out.When the system was turned off to be restarted it counted up (instead of down) for the lamp to cool down.The bulb was replaced without success.When the system was switched on again a system message was displayed without options to continue.The patient did experience harm and there was a 24 hour delay that, per the surgeon, was clinically significant.The surgeon continued the surgery without microscope unable to fold one lens haptic in the bag.The patient was scheduled for a follow up visit.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from the facility.The surgery was completed immediately after the microscope break down using a led desk lamp.The surgery was not aborted.

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.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.(b)(4).

Event Description

Additional information received from the optometrist through a company representative.The patient did not experience any postoperative consequences.

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 cable assembly driver boards were both replaced.The system was tested and found to meet product specifications.The root cause cannot be determined conclusively.(b)(4).

Manufacturer Narrative

Based on information received following submission of the initial and supplemental report, this event does not meet criteria for reporting based on applicable medical device regulations.There is no evidence of a life threatening injury/illness or permanent impairment/damage, there has been no medical or surgical intervention to preclude permanent impairment/damage and the information provided does not represent a product problem that is likely to cause the above-mentioned events if the product problem were to recur.(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: 5317746
• MDR Text Key: 34113066
• Report Number: 2028159-2015-10178
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• 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: 8065752560
• Device Lot Number: ASKU
• Other Device ID Number: 1.02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2015
• 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): Required Intervention
• Patient Age: 77 YR