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 Type  malfunction  

Manufacturer Narrative

The sample has been received and in-house evaluation is in progress.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 one caster of the microscope stand is locking up and is not in good shape.Additional information has been requested.

Manufacturer Narrative

The microscope was examined and the reported ¿caster issue¿ was confirmed.The caster brake assembly was broken.However, it was found to still be load-bearing with no risk of falling.The caster was subsequently replaced to resolve the issue.The system was tested and found to meet product specifications.The microscope was manufactured on june 29, 2015.Based on qa assessment, the product met specifications at the time of release.The caster was received for evaluation.A visual assessment of the returned sample confirmed that the caster wheel detached from the caster assembly.General wear on the caster assembly is observed.No issues were identified with the caster stem.With the information obtained and the sample returning, it was determined that the issue was attributed to a ¿blunt force impact.¿ however, this is unable to be determined conclusively the most likely root cause of the reported event is attributed to blunt force impact.However, this is unable to be determined conclusively.An internal investigation has been opened to address the issue.(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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7169447
• MDR Text Key: 96674760
• Report Number: 2028159-2018-00055
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• 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: 1.04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2015
• 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