FDA Adverse Event
Malfunction
Summary report: N
OCUSCAN RXP
MDR report key: 3221887
·
Received July 9, 2013
Report
- Report Number
- 2028159-2013-01316
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 13, 2013
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- IYO
- PMA / PMN Number
- K842757
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- UNKNOWN
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).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THE BIOMETRY DID NOT WORK AS THE LENS CALCULATIONS WERE INCORRECT. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312649 | OCUSCAN RXP | ULTRASONIC PULSED ECHO IMAGING SYSTEM | IYO | ALCON - IRVINE TECHNOLOGY CENTER | 8065741076 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |