FDA Adverse Event
Injury
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 514942
·
Received March 5, 2004
Report
- Report Number
- 2028159-2004-00057
- Event Type
- Injury
- Date Received
- March 5, 2004
- Date of Event
- January 28, 2004
- Report Date
- February 6, 2004
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER NOTED PT HAD SURGERY IN 2004; COMPLAINED ABOUT PAIN THREE DAYS POST-OP. DIAGNOSED THE FOLLOWING MONTH; TREATMENT WAS STARTED IMMEDIATELY IN ANOTHER HOSP. NO INFO CONCERNING "VA", BUT A VITRECTOMY IS PROBABLE. RESULTS OF BACTERIAL CULTURES ARE NOT YET KNOWN. ADDITIONAL INFO RECEIVED NOTED PT'S PAIN HAS DISAPPEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES TWENTY THOUSAND LEGACY | OPHTHALMIC SURGERY SYSTEM | HQE | ALCON - IRVINE TECHNOLOGY CENTER | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |