FDA Adverse Event
Malfunction
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 201081
·
Received December 3, 1998
Report
- Report Number
- 2028159-1998-00405
- Event Type
- Malfunction
- Date Received
- December 3, 1998
- Date of Event
- October 29, 1998
- Report Date
- November 3, 1998
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTED NOTED HEATING OF HANDPIECE; CORNEAL BURN OCCURRED AT BEGINNING OF U/S PHACO. TREATED WITH STEROIDS TWO WEEKS POST-OP. PROGNOSIS REPORTEDLY GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES TWENTY THOUSAND LEGACY | OPHTHALMIC SURGERY SYSTEM | HQE | ALCON LABORATORIES, INC. | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |