FDA Adverse Event Injury Summary report: N

ACRYSOF TORIC

MDR report key: 2885086 · Received December 19, 2012

Report

Report Number: 1119421-2012-01581
Event Type: Injury
Date Received: December 19, 2012
Date of Event: January 1, 2012
Report Date: November 19, 2012
Manufacturer: ALCON RESEARCH, LTD. / HUNTINGTON
Product Code: HQL
PMA / PMN Number: P930014
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. NOT ENOUGH INFORMATION WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. CITATION: NIENKE VISSER, NOEL J.C. BAUER, RUDY M.M.A. NUJITS. RESIDUAL ASTIGMATISM FOLLOWING TORIC INTRAOCULAR LENS IMPLANTATION RELATED TO PUPIL SIZE. JOURNAL OF REFRACTIVE SURGERY 2012; 28, 10, 729-732. (B)(4).

Description of Event or Problem · 1

IN A JOURNAL ARTICLE, A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT PRESENTED WITH RESIDUAL REFRACTIVE ASTIGMATISM. RESIDUAL ASTIGMATISM OF 0.01 D AT 78 DEGREES WAS ANTICIPATED. NO INTRAOPERATIVE COMPLICATIONS OCCURRED. FOUR MONTHS POSTOPERATIVELY, THE PATIENT PRESENTED WITH A SUBJECTIVE REFRACTION OF 0 - 1.75 AT 95 DEGREES, INDICATIVE OF AN ASTIGMATIC OVERCORRECTION. THE SURGEON REPORTED THAT THE PATIENT'S LARGE PUPIL SIZE MAY HAVE CONTRIBUTED TO THE EVENT, AMONG OTHER FACTORS. THE PATIENT DECLINED FURTHER SURGICAL TREATMENT AND OPTED TO USE SPECTACLES WITH A CYLINDER CORRECTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACRYSOF TORIC	INTRAOCULAR LENS	HQL	ALCON RESEARCH, LTD. / HUNTINGTON	SN60T5	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Other