FDA Adverse Event
Injury
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 949245
·
Received November 15, 2007
Report
- Report Number
- 2028159-2007-00495
- Event Type
- Injury
- Date Received
- November 15, 2007
- Date of Event
- January 1, 2007
- Report Date
- October 16, 2007
- Manufacturer
- ALCON - IRVINCE TECH CTR
- Product Code
- HQE
- PMA / PMN Number
- K911808
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER STATED THAT THE EVENT HAD OCCURRED TWO OR THREE WEEKS BEFORE. THIS WOULD HAVE MADE THE EVENT DATE IN 2007. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN THE SURGEON WAS VACUUMING THE CAPSULE DURING THE I/A STEP OF THE PROCEDURE, A POSTERIOR CAPSULE TEAR OCCURRED. THE SURGEON SPECULATED THAT THERE WAS A POSSIBLE DEFECT ON THE I/A TIP. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES TWENTY THOUSAND LEGACY | OPTHALMIC SURGERY SYSTEM | HQE | ALCON - IRVINCE TECH CTR | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Disability |