FDA Adverse Event Malfunction Summary report: N

CONSTELLATION WITH LASER

MDR report key: 1940429 · Received December 17, 2010

Report

Report Number: 2028159-2010-02406
Event Type: Malfunction
Date Received: December 17, 2010
Date of Event: November 19, 2010
Report Date: November 19, 2010
Manufacturer: ALCON - IRVINE TECHNOLOGY CENTER
Product Code: HQC
PMA / PMN Number: K063583
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: DA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A CASSETTE HAS BEEN RETURNED AND IN-HOUSE EVALUATION IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

Description of Event or Problem · 1

A SURGEON REPORTED THAT THE AUTO STOP COCK VALVE FAILED AND AN INFLOW OF AIR WAS DELIVERED INTO THE PT'S EYE. THE EYE WAS NOT FILLED WITH FLUID AS WAS INTENDED. A SECOND INFUSION TUBING SET WAS CONNECTED. THIS TUBING SET ALSO FAILED AND ADD'L AIR WAS UNINTENTIONALLY DELIVERED TO THE EYE. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A THIRD TUBING SET. THE SURGEON STATED THIS EVENT RESULTED IN PROLONGATION OF THE SURGERY AND MORE DIFFICULT OPERATING CONDITIONS. CONSEQUENCES FOR THE PT CANNOT BE DETERMINED AT PRESENT, BUT THE SURGEON STATES THE INCIDENT DID NOT PRESUMABLY WORSEN THE PROGNOSIS. ADD'L INFO WAS RECEIVED FROM THE SURGEON STATING THAT DURING VITRECTOMY, THE MACHINE STARTED TO PUMP AIR IN THE EYE UNINTENTIONALLY. AIR BUBBLES WERE OBSERVED IN THE EYE. A CONSULTANT PROVIDED ADD'L INFO BY QUESTIONNAIRE STATING THE PT'S POSTOPERATIVE UNCORRECTED VISION IS HAND MOTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CONSTELLATION WITH LASER	UNIT, PHACOFRAGMENTATION	HQC	ALCON - IRVINE TECHNOLOGY CENTER	CONSTELLATION	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR