FDA Adverse Event
Injury
Summary report: N
UNIVERSAL PEA
MDR report key: 83405
·
Received April 12, 1997
Report
- Report Number
- 2028159-1997-00063
- Event Type
- Injury
- Date Received
- April 12, 1997
- Report Date
- March 13, 1997
- Manufacturer
- ALCON LABORATORIES
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H10; THE COMPLAINT STATED THAT THE UNIVERSAL UNIT WAS SUSPECTED AS THE CAUSE OF THREE CASES OF ENDOPHTHALMITIS. FURTHER INVESTIGATION REVEALED THERE WAS NO ENDOPHTHALMITIS, BUT POST SURGICAL INFLAMMATION WHICH THE DR. DOES NOT ATTRIBUTE TO THE MACHINE.
Description of Event or Problem · 1
REPORTED THREE CASES OF ENDOPHTHALMITIS. THE MACHINE IS SUSPECTED BUT NO SAMPLING HAS BEEN MADE OF THE MACHINE OR THE PTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL PEA | PHACOEMULSIFICATION-ASPIRATION SYSTEM | HQE | ALCON LABORATORIES | UNIVERSAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |