FDA Adverse Event
Malfunction
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 294057
·
Received September 1, 2000
Report
- Report Number
- 2028159-2000-00212
- Event Type
- Malfunction
- Date Received
- September 1, 2000
- Date of Event
- August 8, 2000
- Report Date
- August 9, 2000
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
RPTR NOTED THAT FOLLOWING A SOFTWARE UPGRADE THEY HAD FOUR POSTERIOR CAPSULE TEARS OUT OF 25 CASES OVER THREE DAYS WITH TWO SURGEONS. UNITS HAVE BEEN USED SINCE WITHOUT PROBLEM. THE PT DID NOT REQUIRE A VITRECTOMY, AND IOL WAS IMPLANTED.
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 |