FDA Adverse Event Injury Summary report: N

INFINITI VISION SYSTEM

MDR report key: 3891765 · Received June 10, 2014

Report

Report Number: 2028159-2014-01102
Event Type: Injury
Date Received: June 10, 2014
Date of Event: May 1, 2014
Report Date: May 12, 2014
Manufacturer: ALCON - IRVINE TECHNOLOGY CENTER
Product Code: HQC
PMA / PMN Number: K112425
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADD'L INFO HAS BEEN REQUESTED. 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

INITIALLY IT WAS REPORTED BY AN OPERATING ROOM COORDINATOR THAT THERE WAS A HANDPIECE ISSUE. ADD'L DETAILS WERE PROVIDED BY THE SURGICAL TECHNICIAN WHO INDICATED THAT WHILE THE SURGEON WAS PERFORMING AN ANTERIOR VITRECTOMY PROCEDURE TO ADDRESS A POSTERIOR CAPSULE HOLE ON PT'S RIGHT EYE, THERE WAS TOO MUCH INFUSION BECAUSE SHE HAD NOT ATTACHED THE IRRIGATION CANNULA TO THE ANTERIOR VITRECTOMY PROBE. THE INITIAL SURGERY WAS NOT COMPLETED. THE PT RETURNED FOR ADD'L SURGERY WITH A RENAL SURGEON WHO PERFORMED AN ANTERIOR VITRECTOMY AND SUTURED AN INTRAOCULAR LENS IMPLANT. IT IS UNK IF THE POSTERIOR CAPSULE HOLE OCCURRED DURING INITIAL PROCEDURE OR IF IT WAS PREEXISTING. ADD'L INFO HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
340270	INFINITI VISION SYSTEM	PHACOFRAGMENTATION SYSTEM	HQC	ALCON - IRVINE TECHNOLOGY CENTER	INFINITI V3.0	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Required Intervention	INFINITI ULTRAVIT 23GAUGE ANTERIOR VITRECTOMY PAK