FDA Adverse Event
Injury
Summary report: N
SYNERGETIC 23G CHANDELIER
MDR report key: 1953653
·
Received January 4, 2011
Report
- Report Number
- MW5018891
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- May 16, 2009
- Report Date
- January 3, 2011
- Manufacturer
- SYNERGETIC
- Product Code
- FSY
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CHANDELIER IMPLANTED AT 12 O'CLOCK DURING VITRECTOMY LEFT EYE, TOUCHED HUMAN LENS, CATARACT FORMATION, NEEDED CATARACT SURGERY DURING INITIAL SURGERY. NEEDED ANOTHER SURGERY FOR INTRAOCULAR LENS IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGETIC 23G CHANDELIER | CHANDELIER LIGHT 23G | FSY | SYNERGETIC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Disability |