FDA Adverse Event Injury Summary report: N

VISCOAT

MDR report key: 2032425 · Received March 25, 2011

Report

Report Number: 3002037047-2011-00013
Event Type: Injury
Date Received: March 25, 2011
Date of Event: February 25, 2011
Report Date: February 25, 2011
Manufacturer: ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
Product Code: LZP
PMA / PMN Number: P840064
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TU
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE BATCH RECORD REVIEW REVEALED ALL TESTING RESULTS ARE WITHIN SPECIFICATION. INVESTIGATION OF OUR BATCH RECORD SHOWED NO REMARKS RELATED TO THIS COMPLAINT IN THE BATCH RECORD. THERE WERE NO SIMILAR REPORTS FOR THIS LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 02/28/2011, 03/02/2011 AND 03/16/2011. ADDITIONAL INFORMATION WAS RECEIVED ON 03/01/2011. (B)(4).

Description of Event or Problem · 1

A SURGEON REPORTED A CASE OF ENDOPHTHALMITIS. ONE WEEK FOLLOWING SURGERY, THE PATIENT RETURNED TO THE HOSPITAL WITH RED EYES. A VITRECTOMY WAS PERFORMED AND THE PATIENT WAS OBSERVED IN THE HOSPITAL UNDER OBSERVATION. THE PATIENT WAS TREATED WITH MEDICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VISCOAT	AID, SURGICAL, VISCOELASTIC	LZP	ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.	NA	08C20B

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Required Intervention	DEXAMETHASONE\| CIPRO 500 MG TABLET\| TROPAMID\| COSOPT\| VIGAMOX