FDA Adverse Event
Injury
Summary report: N
WHITESTAR SIGNATURE SYSTEM
MDR report key: 1855112
·
Received September 29, 2010
Report
- Report Number
- 2020664-2010-00105
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- September 8, 2010
- Report Date
- September 8, 2010
- Manufacturer
- ABBOTT MEDICAL OPTICS (AMO)
- Product Code
- HQC
- PMA / PMN Number
- K060366
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION IN SECTION F PROVIDED BY THE MANUFACTURER. THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY AN AMO SERVICE TECHNICIAN. THERE WERE NO ISSUES DETECTED WITH THE OPERATION OF THE MACHINE. THE MACHINE WAS FOUND TO MEET AMO SPECIFICATIONS. THE TECHNICIAN WAS NOT ABLE TO IDENTIFY AN EXPLANATION FOR THE EVENT. AS A PROACTIVE MEASURE, THE FOOT PEDAL WAS REPLACED. THE SYSTEM IS CONTINUING TO BE USED WITHOUT FURTHER REPORTED INCIDENTS.
Description of Event or Problem · 1
DURING A PHACOEMULSIFICATION PROCEDURE, THE DOCTOR REPORTED THAT THE REFLUX MODE OF THE PHACO MACHINE WOULD NOT ACTIVATE AND RESULTED IN A CAPSULAR TEAR IN THE PATIENT'S OPERATIVE EYE. THE PATIENT REQUIRED A VITRECTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WHITESTAR SIGNATURE SYSTEM | HQC | ABBOTT MEDICAL OPTICS (AMO) | NGP680300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |