FDA Adverse Event
Injury
Summary report: N
VISITEC CORTICAL CLEAVING HYDRODISSECTOR (FLAT END) .40 X 22MM (27G X 7/8 IN)
MDR report key: 10121050
·
Received June 4, 2020
Report
- Report Number
- 1211998-2020-00266
- Event Type
- Injury
- Date Received
- June 4, 2020
- Date of Event
- February 7, 2020
- Report Date
- June 4, 2020
- Manufacturer
- BEAVER VISITEC INTERNATIONAL, INC
- Product Code
- HMX
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF THE COMPLAINT IS ONGOING. NO ADDITIONAL INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
A CUSTOMER REPORTED THE CANNULA BECAME DISLODGED FROM THE SYRINGE DURING A CATARACT PROCEDURE AND CAUSED A VITREOUS HEMORRHAGE. ADDITIONAL PATIENT INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 582823 | VISITEC CORTICAL CLEAVING HYDRODISSECTOR (FLAT END) .40 X 22MM (27G X 7/8 IN) | VISITEC® CORTICAL CLEAVING HYDRODISSECTOR (FLAT END) .40 X 22MM (27G X 7/8 IN) | HMX | BEAVER VISITEC INTERNATIONAL, INC | 6008235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |