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

Model Number X-SPM

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

An opthalmic surgeon reported that the microscope digital markings were "dancing" or "jumping" during intraocular lens (iol) implant in several patients.The digital marking were used in parallel with manual markings and during surgery the surgeon observed a "jump in the axis" of the microscope guidance for marking.The iols were placed according to the manual markings and the postoperative outcome was very good with no residual astigmatism.Additional information has been requested but received to date.This is one of four medical device reports being filed for this facility.

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.Additional information has been requested but not received to date.(b)(4).

• Brand Name: VERION DIGITAL MARKER M FOR ZEISS 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 ; GM
• Manufacturer Contact: janet moran ; 6201 south freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4016851
• MDR Text Key: 4876557
• Report Number: 3010300699-2014-00001
• Device Sequence Number: 1
• Product Code: FTH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Type of Report: Initial
• Report Date: 07/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• 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: 80659998244
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/04/2014
• 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