FDA Adverse Event Malfunction Summary report: N

ALLEGRO TOPOLYZER VARIO

MDR report key: 10593672 · Received September 28, 2020

Report

Report Number: 3003288808-2020-00579
Event Type: Malfunction
Date Received: September 28, 2020
Date of Event: September 5, 2020
Report Date: December 9, 2020
Manufacturer: WAVELIGHT GMBH
Product Code: MMQ
PMA / PMN Number: EXEMPT
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KZ
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. ACCORDING TO THE INFORMATION FROM CLINICAL APPLICATIONS SPECIALIST (CAS) THERE WERE NO FURTHER PROBLEMS WITH THE DATABASE AFTER THE FIELD SERVICE ENGINEER (FSE) HAD SET THE SETTINGS AT THE SERVER AND REPLACED THE UPS (UNINTERRUPTIBLE POWER SUPPLY). MOST PROBABLY THE UNSTABLE ELECTRICITY AFFECTED THE SERVER DATA SETTINGS. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative · 1

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).

Description of Event or Problem · 1

A SURGEON REPORTED MEASUREMENTS FROM DIFFERENT PATIENTS APPEARED UNDER ONE PATIENT NAME. THE NEWLY CREATED PATIENT HAD MEASUREMENTS INCLUDED FROM ANOTHER PATIENT. THE MEASUREMENTS WERE COMPLETED AND THERE WAS NO HARM TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1059462	ALLEGRO TOPOLYZER VARIO	TOPOGRAPHER, CORNEAL, AC-POWERED	MMQ	WAVELIGHT GMBH	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1