FDA Adverse Event
Injury
Summary report: N
ORA SYSTEM 2000
MDR report key: 8102712
·
Received November 26, 2018
Report
- Report Number
- 2028159-2018-02452
- Event Type
- Injury
- Date Received
- November 26, 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
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
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).
Additional Manufacturer Narrative · 1
BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED A PATIENT PRESENTED WITH BLURRY DISTANCE VISION IN THE LEFT EYE BUT THE PATIENT CAN READ THE NEWSPAPER POST INTRAOPERATIVE ABERROMETRY. THE PATIENT WAS NOTED TO HAVE A POOR REFRACTIVE OUTCOME. ADDITIONAL INFORMATION REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 942703 | ORA SYSTEM 2000 | ABERROMETER, OPHTHALMIC | NCF | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |