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

Catalog Number 8065990710

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2019

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 device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.(b)(4).

Event Description

A facility representative reported during measurement testing prior to refractive treatment, the measurements were not correct.The measurements were not used during surgery and there was no patient impact.

Manufacturer Narrative

During technical review the field service engineer (fse) performed the calibration with model eye and found all measurement values in range.Measurement was also checked on human eyes and found to be normal.No technical root cause was identified as the product was found to be within specifications.The root cause could not be determined 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: 8776836
• MDR Text Key: 150810074
• Report Number: 3003288808-2019-00708
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990710
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1