FDA Adverse Event
Malfunction
Summary report: N
STELLARIS OPTIMIZED STABILITY VACUUM PACK
MDR report key: 2191054
·
Received July 19, 2011
Report
- Report Number
- 1920664-2011-00084
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 21, 2011
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- HQC
- PMA / PMN Number
- K063331
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE IRRIGATION TUBING WAS RECEIVING FROM THE USER FACILITY IN A CONDITION THAT PRECLUDED TESTING OF THE DEVICE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED FROM JAPAN INDICATING THE FOLLOWING: DURING PHACOEMULSIFICATION PHASE WITH 2-PHENYLETHYL ACRYLATE (PEA) THE ANTERIOR CHAMBER DEFLATED SUDDENLY. THE USER FACILITY INDICATED IT MAY BE DUE TO "WEAK IRRIGATION". IT WAS REPORTED THAT "THE CHAMBER BECAME EMPTY DURING SURGERY AND THEN THE BALANCED SALT SOLUTION (BSS) DID NOT FLOW". THE DOCTOR REPLACED THE PACK WITH ANOTHER ONE AND COMPLETED THE PROCEDURE. "NO FURTHER PATIENT INJURY REPORTED. THE PATIENT RECOVERED, NO INJURY REMAINS".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STELLARIS OPTIMIZED STABILITY VACUUM PACK | HQC | BAUSCH & LOMB, INC. | BL5112 | U5527 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |