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 Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923); Inadequate Lighting (2957)

Patient Problem Vitrectomy (2643)

Event Date 05/26/2015

Event Type  Injury  

Event Description

A surgeon reported that the microscope fix during the capsulorhexis step of a cataract surgery.The microscope did not move and the light was also off.The surgeon stopped the surgery and pulled out the forceps from the patient´s eye because of the light issue.The staff changed to another microscope to complete the surgery.As result of the event the patient had rhexis´ leak with vitreous spillage.An anterior vitrectomy was performed in addition to the cataract removal.The patient also showed a dislocation of the lens.Additional information has been requested but not received to date.

Event Description

Additional information was received.The affected eye was the left eye (os).The patient´s symptoms were resolved after treatment.

Manufacturer Narrative

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 but not received to date.(b)(4).

Manufacturer Narrative

Manufacturer Narrative

Evaluation summary: a company representative reviewed the file.No further information was able to be obtained from this customer.With no additional, related information provided, the reported event was not able to be confirmed.The system met specifications at the time of release.The root cause cannot be determined conclusively.

• 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: 4839981
• MDR Text Key: 5874831
• Report Number: 2028159-2015-06435
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• 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: 8065752568
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Date Device Manufactured: 09/04/2014
• 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
• Treatment: DUOVISC
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 79 YR