FDA Adverse Event Injury Summary report: N

CRYSTALENS

MDR report key: 1192584 · Received October 8, 2008

Report

Report Number: 2031924-2008-00300
Event Type: Injury
Date Received: October 8, 2008
Date of Event: July 22, 2008
Report Date: August 12, 2008
Manufacturer: BAUSCH & LOMB SURGICAL
Product Code: HQL
PMA / PMN Number: P030002
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THE LENS WAS RETURNED TO B&L FOR EVALUATION AND THE FINDINGS REVEAL THE LENS OPTIC WAS CUT IN HALF. THE CONDITION OF THE LENS IS CONSISTENT WITH FINDINGS FOR IOLS THAT HAVE BEEN EXPLANTED, SINCE LENS DAMAGE IS EXPECTED TO OCCUR DURING THE EXPLANT PROCEDURE. ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE ROOT CAUSE OF THE REPORTED PROBLEM WAS RELATED TO THE SMALL OPTIC SIZE.

Description of Event or Problem · 1

THE PHYSICIAN REPORTS PERFORMING UNEVENTFUL CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE PATIENT'S RIGHT EYE. IMMEDIATELY POSTOPERATIVELY, THE PATIENT COMPLAINED OF GLARE AND NEGATIVE DYSPHOTOPSIA WITH A BLIND SPOT IN HIS MID-PERIPHERAL VISION. TWO MONTHS POSTOPERATIVELY, THE LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT LENS MODEL. PREOPERATIVELY, THE PATIENT'S BCVA OD WAS 20/40, MRSE WAS -0.25 SPH. POSTOPERATIVELY AND PRIOR TO THE LENS EXCHANGE, THE PATIENT'S BCVA IMPROVED TO 20/15, UCNVA WAS J3 AND MRSE WAS -0.50 SPH. THE PHYSICIAN BELIEVES THE CAUSE OF THE EVENT IS RELATED TO THE PATIENT'S INTOLERANCE OF THE 5.0 MM OPTIC SIZE. ONCE THE LENS WAS EXCHANGED, THE BCVA WAS 20/15, MRSE WAS -0.25 SPH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CRYSTALENS	INTRAOCULAR LENS	HQL	BAUSCH & LOMB SURGICAL	AT50SE	013339

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Required Intervention