FDA Adverse Event Other Summary report: N

UNKNOWN

MDR report key: 3122643 · Received May 17, 2013

Report

Report Number: 9611165-2013-00033
Event Type: Other
Date Received: May 17, 2013
Report Date: November 29, 2012
Manufacturer: RAYNER INTRAOCULAR LENSES LIMITED
Product Code: HQL
PMA / PMN Number: P060011
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PT UNDERWENT AN IOL EXCHANGE PROCEDURE ON (B)(6) 2013. THE AVAILABLE INFO ALSO INDICATES THAT THE CAPSULAR TENSION RING (CTR) WAS TEASED OFF DURING THIS SURGERY AND THAT AN ANTERIOR VITRECTOMY WAS PERFORMED. ANALYSIS OF THE IOL WAS UNDERTAKEN BY A THIRD PARTY INDEPENDENT LABORATORY. THE DEVICE ANALYSIS PERFORMED BY THE LABORATORY CONCLUDED THAT "SEM AND EDX SPECTROSCOPY SHOWED THAT THERE WERE NO INORGANIC DEPOSITS ON OR BELOW THE SURFACE OF THE IOL. THERE WERE, HOWEVER, DEPOSITS ON THE IOL DETECTABLE WHICH SEEMED TO CONSIST OF ORGANIC MATERIAL (PROTEINS, CELLS ETC)." THE DEVELOPMENT OF "OPACIFICATION" IN THIS CASE CANNOT BE ATTRIBUTED TO THE IOLS MATERIAL OR DESIGN. THE RESULTS OF THE DEVICE ANALYSIS INDICATE THAT PROTEIN AND CELL GROWTH HAS CAUSED THE APPEARANCE OF "OPACIFICATION."

Description of Event or Problem · 1

RAYNER INTRAOCULAR LENSES REC'D NOTIFICATION FROM (B)(6) OF AN EVENT THAT OCCURRED FOLLOWING DESCEMET'S STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY (DSAEK) SURGERY AND REPEAT AIR BUBBLE SURGERY. THE EVENT DESCRIPTION PROVIDED INDICATES THAT THE HEALTHCARE PROFESSIONAL OBSERVED THE DEVELOPMENT OF OPACIFICATION IN THE IMPLANTED INTRAOCULAR LENS (IOL) POST THESE ADD'L SURGICAL PROCEDURES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
219028	UNKNOWN	HQL - INTRAOCULAR LENS	HQL	RAYNER INTRAOCULAR LENSES LIMITED	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1