FDA Adverse Event
Injury
Summary report: N
TECNIS CL
MDR report key: 2070300
·
Received April 18, 2011
Report
- Report Number
- 2648035-2011-00065
- Event Type
- Injury
- Date Received
- April 18, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 22, 2011
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- HQL
- PMA / PMN Number
- P980040/R
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A POSTERIOR CHAMBER TEAR AND VITREOUS PROLAPSE. THE IOL WAS REMOVED WITH THE INCISION ENLARGED. THERE WAS NO INJURY TO THE PATIENT. THE DOCTOR USED AN ANTERIOR CHAMBER LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TECNIS CL | MONOFOCAL LENS | HQL | ABBOTT MEDICAL OPTICS | Z9002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |