FDA Adverse Event
Injury
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 362315
·
Received November 14, 2001
Report
- Report Number
- 2648766-2001-00344
- Event Type
- Injury
- Date Received
- November 14, 2001
- Date of Event
- October 15, 2001
- Report Date
- October 15, 2001
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER NOTED TWO PATIENTS HAD A PNEUMOCOCCUS INFECTION AFTER PHACO PROCEDURES. MULTIPLE PRODUCTS USED; TRYING TO IDENTIFY CAUSE. OBSERVED STERILIZATION PROCEDURE OF PHASCO SETS AT HOSPITAL "CSA" ON 10/16/2001. NOTED THAT ONE I/A HANDPIECE WAS OBSTRUCTED; DIFFICULT TO REMOVE OBSTRUCTION. THIN LAYER OF POWDER NOTED ON INSTRUMENT TRAY AND HANDPIECE. POWDER IDENTIFIED AS LIME: SOURCE UNKNOWN. ALL CULTURES WERE NEGATIVE. RESUMED SURGERIES SEVERAL DAYS LATER. PATIENT 2 OF 2: NO INTERVENTION OR PROGNOSIS REPORTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51504 | SERIES TWENTY THOUSAND LEGACY | OPHTHALMIC SURGERY SYSTEM | HQE | ALCON - IRVINE TECHNOLOGY CENTER | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |