FDA Adverse Event
Malfunction
Summary report: N
SCROLL PHACO PACK
MDR report key: 298184
·
Received September 26, 2000
Report
- Report Number
- 1119279-2000-00244
- Event Type
- Malfunction
- Date Received
- September 26, 2000
- Date of Event
- August 23, 2000
- Report Date
- August 28, 2000
- Manufacturer
- BAUSCH & LOMB SURGICAL
- Product Code
- HQE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE COMPLAINT STATED THIS PRODUCT HAD INADEQUATE ASPIRATION DURING A CATARACT PHACOEMULSIFICATION PROCEDURE. THERE WAS NO ADVERSE EFFECT ON THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCROLL PHACO PACK | OPHTHALMIC MICROSURGICAL ACCESSORY PACK | HQE | BAUSCH & LOMB SURGICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |