FDA Adverse Event
Other
Summary report: N
CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR
MDR report key: 12402
·
Received March 29, 1994
Report
- Report Number
- MW1001324
- Event Type
- Other
- Date Received
- March 29, 1994
- Date of Event
- February 24, 1994
- Report Date
- March 10, 1994
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
SURGEON STATED TIP OF PHACOEMULSIFIER BECAME HOT AND CORNEAL TISSUE SHRANK AT END OF PHACOEMULSIFICATION OF LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR | PHACO-EMULSIFIER ASPIRATOR | HQC | ALCON LABORATORIES, INC. | 9001T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other | NO FURTHER TREATMENT DONE SO FAR.| WKLY POSTOP CHECKS BY SURGEON. |