FDA Adverse Event Malfunction Summary report: N

ORA SYSTEM 2000

MDR report key: 8074129 · Received November 15, 2018

Report

Report Number: 2028159-2018-02408
Event Type: Malfunction
Date Received: November 15, 2018
Date of Event: October 24, 2018
Report Date: January 24, 2019
Manufacturer: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
Product Code: NCF
PMA / PMN Number: EXEMPT
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THAT THE ABERROMETER FELL FROM THE MICROSCOPE, WHICH RESULTED IN A LOOSE OPTIC. THE ABERROMETER WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ABERROMETER IS MOUNTED UNDERNEATH THE MICROSCOPE VIA FEMALE/MALE DOVETAIL THAT ENABLES THE ABERROMETER TO THE REMOVED AND REPLACED ONTO THE MICROSCOPE PER THE CUSTOMER¿S PREFERENCE. THUS, IT IS LIKELY THAT THE ABERROMETER FALLING WAS A RESULT OF THE CUSTOMER HANDLING. HOWEVER, WITH THE INFORMATION PROVIDED, THIS IS UNABLE TO BE DETERMINED CONCLUSIVELY. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT 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. (B)(4).

Description of Event or Problem · 1

A COMPANY REPRESENTATIVE REPORTED THAT THE ABERROMETER FELL OFF THE MICROSCOPE. A LOOSE OPTIC WAS REPORTED. A NEW ABERROMETER WILL BE ORDERED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
916274	ORA SYSTEM 2000	ABERROMETER, OPHTHALMIC	NCF	ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER	NA	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1