FDA Adverse Event Injury Summary report: N

CRYSTALENS

MDR report key: 1033365 · Received April 24, 2008

Report

Report Number: 2031924-2008-00165
Event Type: Injury
Date Received: April 24, 2008
Date of Event: February 28, 2008
Report Date: March 5, 2008
Manufacturer: EYEONICS, INC.
Product Code: HQL
PMA / PMN Number: P030002
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE REMAINS IMPLANTED AND IS, THEREFORE, NOT AVAILABLE FOR EVAL. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. OTHER: THE LENS WAS IN A Z CONFIGURATION, WHICH CAUSED THE LENS OPTIC TO IRRITATE THE IRIS AND, CONSEQUENTLY, PIGMENT DISPERSION WAS OBSERVED.

Description of Event or Problem · 1

A PHYSICIAN REPORTS THAT A PT UNDERWENT UNEVENTFUL CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE LEFT EYE. AT POSTOP DAY #43, THE DILATED EXAM WAS NOTABLE FOR SOME VERTICAL CAPSULAR STRIAE THROUGH THE VISUAL AXIS. THE LENS WAS IN A NEUTRAL POSITION, BUT THE STRIAE CAUSED SOME LIMITATION OF VISION (UCVA 20/80, BCVA 20/40), BUT WAS EXPECTED TO RESOLVE WITH TIME. IN 2008, THE PT RETURNED FOR A VISIT AND REPORTED THAT SHE NO LONGER NEEDED GLASSES FOR DISTANCE AND INTERMEDIATE ACTIVITIES, BUT THAT SHE WORE READING GLASSES. THE PT ALSO REPORTED THAT THE IOL DID NOT "FEEL" LIKE IT WAS IN THE CORRECT POSITION. THE DILATED EXAMINATION SHOWED THE LENS IN A Z-CONFIGURATION, WHERE THE INFERIOR PORTION OF THE OPTIC WAS RUBBING AGAINST THE POSTERIOR IRIS. OF IMPORTANCE, PIGMENT DISPERSION WAS OBSERVED. THE HAPTICS WERE IN THE BAG AND A YAG PROCEDURE WAS PERFORMED THE FOLLOWING MONTH TO REPOSITION THE LENS. CURRENT BCVA WAS 20/30.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CRYSTALENS	INTRAOCULAR LENS	HQL	EYEONICS, INC.	AT50SE	009297

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR		Required Intervention