MAUDE Adverse Event Report: WAVELIGHT GMBH (AGPS) VERION DIGITAL MARKER M FOR LEICA MICROSCOPES; CAMERA, STILL, MICROSURGICAL

Model Number X-SPM

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

A surgeon reported that during intraocular lens (iol) alignment to the vertical axis, the digital marker indicated a second vertical axis at 20-30 degrees.This event was reported to have been observed twice.No pt harm was reported.Add'l info has been requested, but not received to date.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with cfr 803.56 when add'l reportable info becomes available.Add'l info has been requested but not received to date.(b)(4).

• Brand Name: VERION DIGITAL MARKER M FOR LEICA MICROSCOPES
• Type of Device: CAMERA, STILL, MICROSURGICAL
• Manufacturer (Section D): WAVELIGHT GMBH (AGPS); am wolfsmantel 5; erlangen 9105 8; GM 91058
• Manufacturer (Section G): WAVELIGHT GMBH (AGPS); am wolfsmantel 5; erlangen 9105 8; GM 91058
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-14; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4280320
• MDR Text Key: 15114358
• Report Number: 3010300699-2014-00008
• Device Sequence Number: 1
• Product Code: FTH
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-SPM
• Device Catalogue Number: 8065998242
• Other Device ID Number: 2.5.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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 Age: 65 YR
• Patient Weight: 80