FDA Adverse Event Injury Summary report: N

CONSTELLATION WITH LASER

MDR report key: 2073605 · Received April 27, 2011

Report

Report Number: 2028159-2011-00442
Event Type: Injury
Date Received: April 27, 2011
Date of Event: March 23, 2011
Report Date: March 28, 2011
Manufacturer: ALCON - IRVINE TECHNOLOGY CENTER
Product Code: HQC
PMA / PMN Number: K063583
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE IS UNK AT THIS TIME. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/27/2011. (B)(4).

Description of Event or Problem · 1

A SURGEON REPORTED TWO INSTANCES OF MASSIVE UVEITIS. THIS REPORT CONCERNS THE FIRST PT, A (B)(6) YEAR OLD MALE. THE SURGEON REPORTED THAT THE PT UNDERWENT CATARACT/VITRECTOMY SURGERY AND SUBSEQUENTLY DEVELOPED A "MASSIVE UVEITIS" POSTOPERATIVELY. IT WAS FOUND PREDOMINANTLY IN THE VITREOUS AND CELL AGGLUTINATIONS ARE VISIBLE. THE SURGEON SUSPECTED THIS TO BE A "TOXIC HYPERERGICAL REACTION". HE MENTIONED THAT VISUALLY INSPECTED IT LOOKED LIKE A MASSIVE ENDOPHTHALMITIS AND LIKE THE DESCRIBED REACTIONS AFTER INJECTIONS OF AVASTIN (BEVACIZUMAB) IN LITERATURE ARTICLES. ADDITIONAL INFO HAS BEEN REQUESTED NUMEROUS TIMES, BUT NO FURTHER INFO HAS BEEN PROVIDED.

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	71 YR		Required Intervention