MAUDE Adverse Event Report: ALCON MANUFACTURING, LTD. LUXOR; MICROSCOPE, OPERATING & ACC, AC-POWERED OPHTHALMIC

Model Number LUXOR

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 12/19/2013

Event Type  Injury  

Event Description

A surgeon reported that there was no red reflex from the microscope which he felt caused a posterior capsular tear during a surgical procedure.After the intraocular lens implantation the surgeon noticed vitreous present in the anterior chamber and performed a manual anterior vitrectomy to address the posterior capsular tear.The microscope was exchanged to complete the procedure with no further harm to the patient.Add'l info has been requested.

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 add'l reportable info becomes available.(b)(4).

• Brand Name: LUXOR
• Type of Device: MICROSCOPE, OPERATING & ACC, AC-POWERED OPHTHALMIC
• Manufacturer (Section D): ALCON MANUFACTURING, LTD.; 15800 alton pkwy.; irvine CA 92618 381
• Manufacturer (Section G): ALCON MANUFACTURING, LTD.; 15800 alton pkwy.; irvine CA 92618 381
• Manufacturer Contact: janet moran ; 6201 south freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3596607
• MDR Text Key: 4071399
• Report Number: 2028159-2014-00100
• Device Sequence Number: 1
• Product Code: GES
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUXOR
• Device Catalogue Number: 8065752239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MIOCHOL; INFINITI VISION SYSTEM; LENSX; WESTCOTT SCISSORS; LEICA MICROSCOPE
• Patient Outcome(s): Required Intervention