EX-PRESS MINI GLAUCOMA SHUNT

Report

Report Number: 3003701944-2012-00087
Event Type: Injury
Date Received: December 7, 2012
Date of Event: January 1, 2007
Report Date: November 7, 2012
Manufacturer: OPTONOL, LTD
Product Code: KYF
PMA / PMN Number: K030350
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE, THE LOT OR SERIAL NUMBERS WERE NOT PROVIDED BY THE REPORTER. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, THE SURGEON WAS UNABLE TO PROVIDE FURTHER INFORMATION. CITATIONS: KATHRYN B. FRIEDL, MARLENE R. MOSTER. EXPRESS SHUNT SURGERY: PREFERRED GLAUCOMA SURGERY IN RESIDENCY TRAINING? SURV OPHTHALMOL. 2012;57, 372-375. PETER J. G. MARIS, JR, KYOKO ISHIDA, AND PETER A. NETLAND. COMPARISON OF TRABECULECTOMY WITH EX-PRESS MINIATURE GLAUCOMA DEVICE IMPLANTED UNDER SCLERAL FLAP. JOURNAL OF GLAUCOMA. 2007;16. 14-19. (B)(4).

Description of Event or Problem · 1

IN A LITERATURE ARTICLE, THE AUTHOR CITED A STUDY IN WHICH A SURGEON PRESENTED THE FOLLOWING EVENTS AFTER SHUNT IMPLANTATION: TWO CASES OF EARLY HYPOTONY, FOUR CASES OF CHOROIDAL EFFUSIONS, ONE CASE OF FLAT ANTERIOR CHAMBER, TWO CASES OF HYPOTONY MACULOPATHY, TWO CASES OF HYPHEMA, THREE BLEB LEAKS, AND ONE CASE OF ENDOPHTHALMITIS. THE SURGEON ALSO PRESENTED FIVE CASES OF DEVICE FAILURE; TWO OF THOSE REQUIRED SECONDARY SURGICAL INTERVENTION. NO PT IDENTIFIERS WERE PROVIDED FOR ANY OF THE CASES PRESENTED. ADDITIONAL INFORMATION WAS REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EX-PRESS MINI GLAUCOMA SHUNT	AQUEOUS SHUNT	KYF	OPTONOL, LTD	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention