MAUDE Adverse Event Report: WAVELIGHT GMBH (AGPS) VERION DIGITAL MARKER M; MARKER, OCULAR

Model Number X-SPM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Visual Impairment (2138); Discomfort (2330)

Event Date 07/06/2017

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.(b)(4).

Event Description

A doctor reported that a green flash from the optic of the microscope dazzled his eyes.The surgeon was performing a toric intraocular lens implant procedure when this occurred.During the surgery, the imaging system bugged.The green flash dazzled the surgeon.The surgeon shouted and experienced discomfort and a white veil appeared in front of his eyes.The incident lasted about 30 seconds.The surgeon was about to finish the surgery he was performing.Surgeon is concerned about potential sequela following the flash.Upon follow up, glare was reported to have lasted about four minutes.Surgeon was afraid of losing part of his vision.There are two related reports for this patient.This report addresses the patient's left eye and another manufacturer report will be filed for the fellow eye.

Manufacturer Narrative

No anomalies found by review of device history record.Product met all specifications when released.At the visit on site, the field service engineer could not reproduce the error.Fse tried by himself during testing and confirms that the microscope integrated display (mid) behaves just like any other mid.Little green light at start up but nothing very intensive.Tuning control/check: test in accordance with the procedure.Control according to procedure-device in keeping with the company specifications.(b)(4).

• Brand Name: VERION DIGITAL MARKER M
• Type of Device: MARKER, OCULAR
• Manufacturer (Section D): WAVELIGHT GMBH (AGPS); rheinstrasse 8; teltow 14513 ; GM 14513
• Manufacturer (Section G): WAVELIGHT GMBH (AGPS); rheinstrasse 8; teltow 14513 ; GM 14513
• Manufacturer Contact: nadia bailey ; rheinstrasse 8; teltow D-145-13 ; GM D-14513 ; 8176152230
• MDR Report Key: 6762958
• MDR Text Key: 81680579
• Report Number: 3010300699-2017-00023
• Device Sequence Number: 1
• Product Code: FTH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: X-SPM
• Device Catalogue Number: 8065998242
• Device Lot Number: ASKU
• Other Device ID Number: 00380659982422
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2017
• 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