FDA Adverse Event
Other
Summary report: N
MALYUGIN RING SYSTEM
MDR report key: 1474563
·
Received September 14, 2009
Report
- Report Number
- 3019924-2009-00003
- Event Type
- Other
- Date Received
- September 14, 2009
- Date of Event
- August 6, 2009
- Report Date
- September 12, 2009
- Manufacturer
- MICROSURGICAL TECHNOLOGY, INC.
- Product Code
- HNI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SURGEON ELECTED NOT TO RETRIEVE THE RING. EARLY POST-OP EXAMINATION SHOWED VERY GOOD RESULTS.
Description of Event or Problem · 1
SURGEON USED MALYUGIN RING TO MANAGE IFIS CONDITION DURING CATARACT PROCEDURE. THE IOL UNFOLDED ON TOP OF THE IRIS AND WHEN IT WAS MANEUVERED INTO POSITION, IT DISENGAGED THE RING PUSHING IT POSTERIORLY AND TRAPPING IT BEHIND THE IOL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALYUGIN RING SYSTEM | IRIS RETRACTOR | HNI | MICROSURGICAL TECHNOLOGY, INC. | MAL-0001 | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 95 YR | Other |