FDA Adverse Event Injury Summary report: N

CRYSTALENS

MDR report key: 1940284 · Received December 17, 2010

Report

Report Number: 2031924-2010-00233
Event Type: Injury
Date Received: December 17, 2010
Report Date: November 17, 2010
Manufacturer: BAUSCH & LOMB
Product Code: NAA
PMA / PMN Number: P030002
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. ACCORDING TO THE SURGEON, THE MOST LIKELY CAUSE OF THE Z-SYNDROME IS DUE TO THE SIZE OF THE IOL IN A RELATIVELY SMALL EYE. CAPSULE FIBROSIS MAY CAUSE MISALIGNMENT OF THE IOL. (B)(4).

Description of Event or Problem · 1

THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS INTRAOCULAR LENS IN THE RIGHT EYE USING THE CI-28 DELIVERY DEVICE. POST-OPERATIVELY, A Z-SYNDROME OCCURRED. THE PATIENT'S PREOPERATIVE BCVA WAS 6/7.5 (20/25) WITH MR + 5.25 - 1.0 X 160. ONE WEEK POSTOPERATIVELY, THE PATIENT'S BCVA WAS 6/7.5 (20/25) AND A LRI WAS PERFORMED. SOME PCO WAS OBSERVED. DOUBLE VISION WAS REPORTED AT APPROXIMATELY SIX WEEKS POSTOPERATIVELY WITH DECREASED VISUAL ACUITY OF 6/15 (20/50). THE SURGEON APPLIED A CENTRAL YAG CAPSULOTOMY AND ATTEMPTED RE-POSITION THE IOL WHICH SLIGHTLY IMPROVED VISUAL ACUITY TO 6/12 (20/40) BUT REVERTED TO 6/15 (20/50) TWO WEEKS POSTOPERATIVELY. THE PATIENT IS SCHEDULED FOR A PLANNED FOLLOW UP TO DECIDE WHETHER TO APPLY A SECOND YAG PROCEDURE OR PERFORM AN IOL EXCHANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. REFERENCE MDR #2031924-2010-00234.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CRYSTALENS	INTRAOCULAR LENS	NAA	BAUSCH & LOMB	AT50AO	017964

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention