FDA Adverse Event Malfunction Summary report: N

ACRYSOF

MDR report key: 3580286 · Received December 10, 2013

Report

Report Number: 1119421-2013-01198
Event Type: Malfunction
Date Received: December 10, 2013
Date of Event: January 1, 2008
Report Date: November 11, 2013
Manufacturer: ALCON- RESEARCH LTD/HUNTINGTON
Product Code: HQL
PMA / PMN Number: P930014
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. CITATION: CHANGE A, ET AL. COMPARISON OF POSTERIOR CAPSULE OPACIFICATION AND GLISTENINGS WITH 2 HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES: 5-7 YEAR FOLLOW-UP J CATARACT REFRACT SURG 2013; 39:694-698. (B)(4).

Description of Event or Problem · 1

THE AUTHORS OF A LITERATURE ARTICLE REPORTED GLISTENINGS IN 23 PATIENTS, BETWEEN 5 AND 7 YEARS AFTER INTRAOCULAR LENS IMPLANTATION. GLISTENINGS WERE CATEGORIZED IN 4 DEGREES (0-3, 3 MEANING SEVERE GLISTENINGS). THE DISTRIBUTION OF PATIENTS WAS: 12 DEGREE 1,6 DEGREE 2, 5 DEGREE 3. NO EFFECTS ON VISUAL ACUITY WERE REPORTED, THE ARTICLE MENTIONED THERE WAS NO CORRELATION BETWEEN THE AMOUNT OF GLISTENINGS AND CONTRAST SENSITIVITY AND CORRECTED DISTANCE VISUAL ACUITY. THE PURPOSE OF THE STUDY WAS TO COMPARE POSTERIOR CAPSULE OPACIFICATION (PCO) AND GLISTENINGS 5 TO 7 YEARS AFTER CATARACT SURGERY WITH IMPLANTATION OF 2 HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES (IOLS) AND EVALUATE THE EFFECTS ON CORRECTED DISTANCE VISUAL ACUITY (CDVA) AND CONTRAST SENSITIVITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
644032	ACRYSOF	INTRAOCULAR LENS	HQL	ALCON- RESEARCH LTD/HUNTINGTON	SA60AT	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1