FDA Adverse Event
Malfunction
Summary report: N
ORA SYSTEM 2000
MDR report key: 7138028
·
Received December 21, 2017
Report
- Report Number
- 2028159-2017-04569
- Event Type
- Malfunction
- Date Received
- December 21, 2017
- Report Date
- April 26, 2018
- 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
- MD, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS NOT REPLICATED. THE ABERROMETER WAS CLEANED AS A PREVENTATIVE MEASURE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. BASED ON QUALITY ASSURANCE ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS. THEREFORE THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED CONCLUSIVELY. (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 CUSTOMER REPORTED THAT THE SYSTEMS CALCULATIONS WERE OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 918367 | ORA SYSTEM 2000 | ABERROMETER, OPHTHALMIC | NCF | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |