FDA Adverse Event
Injury
Summary report: N
CUSTOMEYES
MDR report key: 12921751
·
Received December 2, 2021
Report
- Report Number
- 3002808441-2021-00009
- Event Type
- Injury
- Date Received
- December 2, 2021
- Date of Event
- November 10, 2021
- Report Date
- December 10, 2021
- Manufacturer
- BEAVER VISITEC INTERNATIONAL LIMITED
- Product Code
- PZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE REPORTED IN THIS MDR IS ONLY DISTRIBUTED IN THE EU. THE DEVICE REPORTED IN THIS MDR WAS NOT PREVIOUSLY DISTRIBUTED IN THE USA. MOREOVER, THERE ARE NO SIMILAR DEVICES DISTRIBUTED IN THE USA FROM FEI 3002808441.
Additional Manufacturer Narrative · 0
IT IS ALLEGED THAT PATIENT DEVELOPED (TASS) TOXIC ANTERIOR SEGMENT SYNDROME POST SURGERY.
Description of Event or Problem · 0
THIS MDR WAS FILED IN ERROR.
Description of Event or Problem · 0
IT IS ALLEGED THAT PATIENT DEVELOPED (TASS) TOXIC ANTERIOR SEGMENT SYNDROME POST SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1818929 | CUSTOMEYES | CUSTOM PROCEDURE PACKS | PZG | BEAVER VISITEC INTERNATIONAL LIMITED | 3341679 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |