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 Patient Involvement (2645)

Event Date 03/14/2017

Event Type  malfunction  

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 the set up for an intraocular lens extraction and implant procedure the microscope suddenly dropped when lock released.The case was imitated and completed using alternate microscope.There was no patient involvement.

Manufacturer Narrative

The system was examined and the reported event was replicated.A non-conforming articulating arm assembly was replaced to resolve 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 november 20, 2014.Based on qa assessment, the product met specifications at the time of release.The cause of the reported event can be attributed to non-conforming articulating arm assembly.However, how that articulating arm assembly became non-conforming remains inconclusive.(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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6471268
• MDR Text Key: 72337446
• Report Number: 2028159-2017-01476
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• 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_BLD_0020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2014
• 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