MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRO TOPOLYZER VARIO; TOPOGRAPHER, CORNEAL, AC-POWERED

Catalog Number 8065990710

Device Problem Incorrect Measurement (1383)

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

Event Date 08/15/2019

Event Type  malfunction  

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 health authority reported a customer experienced inaccurate topography measurements on a myopic patient.Additional information is not available.

Manufacturer Narrative

The root cause could not be identified conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALLEGRO TOPOLYZER VARIO
• Type of Device: TOPOGRAPHER, CORNEAL, AC-POWERED
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• MDR Report Key: 9395059
• MDR Text Key: 191321365
• Report Number: 3003288808-2019-01178
• Device Sequence Number: 1
• Product Code: MMQ
• 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,other
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990710
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Patient Sequence Number: 1