FDA Adverse Event
Injury
Summary report: N
IPURE
MDR report key: 17830229
·
Received September 27, 2023
Report
- Report Number
- 1211998-2023-00055
- Event Type
- Injury
- Date Received
- September 27, 2023
- Date of Event
- December 22, 2022
- Report Date
- September 27, 2023
- Manufacturer
- BEAVER-VISITEC INTERNATIONAL, INC.
- Product Code
- HQL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NOTE THAT THE UDI NUMBER IS NOT AVAILABLE AS THE PART AND LOT NUMBER ARE NOT AVAILABLE.
Description of Event or Problem · 0
CUSTOMER ALLEGED THAT THE CAPSULAR BAG WAS TORN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352712 | IPURE | intraocular lens | HQL | BEAVER-VISITEC INTERNATIONAL, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |