MAUDE Adverse Event Report: WAVELIGHT GMBH (AGPS) VERION REFERENCE UNIT; KERATOMETER, PUPILLOMETER

Model Number X-RUS

Device Problem Insufficient Information (3190)

Patient Problem Visual Impairment (2138)

Event Date 10/30/2015

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.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported a case of a refractive outcome surprise three weeks post cataract procedure of the right eye.The reporter indicated the patient displayed an overcorrection of increased cylinder power, thereby increasing the astigmatism.The reporter stated the patient may require photo refractive keratectomy (prk) as intervention.Upon additional follow up, reporter indicated the patient experienced an unrelated cardiac event that required a hospital stay.Once the patient is released by the cardiologist, a lasek procedure will be scheduled.

Manufacturer Narrative

Under the given conditions of an irregular cornea, an irregular cylinder with a difference of the measured steep axis of more than 30° and comparing 1mm to 4mm measurement zone, a crosscheck with alternative diagnostic devices/methods is recommended.The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with irregular corneal astigmatism.No technical root cause could be determined as the system is performing within specifications.(b)(4).

• Brand Name: VERION REFERENCE UNIT
• Type of Device: KERATOMETER, PUPILLOMETER
• Manufacturer (Section D): WAVELIGHT GMBH (AGPS); rheinstrasse 8; telow berlin 14513 ; GM 14513
• Manufacturer (Section G): WAVELIGHT GMBH (AGPS); rheinstrasse 8; telow berlin 14513 ; GM 14513
• Manufacturer Contact: eddie darton, md, jd ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8175686660
• MDR Report Key: 5273818
• MDR Text Key: 32904986
• Report Number: 3010300699-2015-00520
• Device Sequence Number: 1
• Product Code: HLG
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-RUS
• Device Catalogue Number: 8065998240
• Device Lot Number: ASKU
• Other Device ID Number: 00380659982408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 72 YR