FDA Adverse Event
Malfunction
Summary report: N
ORA SYSTEM 2000
MDR report key: 6428512
·
Received March 23, 2017
Report
- Report Number
- 2028159-2017-01248
- Event Type
- Malfunction
- Date Received
- March 23, 2017
- Report Date
- April 25, 2017
- 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
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ROOT CAUSE CANNOT 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 1
AN OFFICE MANAGER REPORTED DURING A CUSTOMER SURVEY, THE SURGEON INDICATED AN INCREASE IN THE RATE OF PATIENT ENHANCEMENTS HAVE OCCURRED AFTER UTILIZING THE OCULAR ABERROMETER DURING CATARACT PROCEDURES. NO ADDITIONAL INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 209382 | ORA SYSTEM 2000 | ABERROMETER, OPHTHALMIC | NCF | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |