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 Postoperative refraction, unexpected (2642)

Event Date 06/04/2014

Event Type  Injury  

Event Description

An ophthalmic surgeon reported that after cataract surgery she identified a deviation in the axis for the implanted toric iol in three patients.During surgery, she saw a rotation of the final axis compared with the initially planned axis.This led to residual astigmatism that was corrected with eye glasses.For this pt surgeon reported a jump on the marks for the incision of 30 degrees.The surgeon indicated the postoperative astigmatism was due to the system makings and not due to a postoperative iol rotation.Additional info was received from the surgeon.During surgery, markings in the microscope and in the display were permanently changing, thus making it difficult to guess which was the correct toric alignment axis.The surgeon chose one of the multiple axis displayed and postoperatively the iol presented a rotation of 12 degrees deviation from the preoperatory axis suggested by the digital marker (164 degree instead of 176 degree).The rotation was observed on the first postoperative day and persisted one month after surgery.The pt was not willing to undergo iol repositioning.Additional 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 21 cfr 803.56 when additional reportable info becomes available.Additional info 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 9105 8; GM 91058
• Manufacturer Contact: janet moran ; 6201 south freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4024527
• MDR Text Key: 4877223
• Report Number: 3010300699-2014-00002
• Device Sequence Number: 1
• Product Code: FTH
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: EXERR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• 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: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-SPM
• Device Catalogue Number: 8065998244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Treatment: AVODART; UNK ACRYSOF TORIC IOL; IZODIENT; ATENOLOL
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR