FDA Adverse Event Injury Summary report: N

ACRYSOF IQ TORIC

MDR report key: 1972366 · Received January 20, 2011

Report

Report Number: 1119421-2011-00040
Event Type: Injury
Date Received: January 20, 2011
Date of Event: January 1, 2010
Report Date: December 21, 2010
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: NJ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVALUATION: THE REPORTED COMPLIANT COULD NOT BE VERIFIED. THE OPTIC WAS TORN/SPLIT (POSSIBLY CUT) INTO TWO PIECES. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE DETERMINED BY THE EVALUATION. LENS BENCH TESTING CANNOT BE CONDUCTED DUE TO THE OPTIC DAMAGE. DUE TO THE PRESENCE OF BLOOD AND SURGICAL SOLUTION, THE DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. (B)(4).

Description of Event or Problem · 1

A TECHNICIAN REPORTED THAT TWO WEEKS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE IOL WAS EXPLANTED BECAUSE THE PATIENT EXPERIENCED RESIDUAL MYOPIA. THE IOL WAS EXCHANGED FOR THE SAME MODEL, DIFFERENT POWER LENS. THE TECHNICIAN REPORTED THAT THE PATIENT WAS HAPPY WITH HER VISION AFTER THE EXCHANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACRYSOF IQ TORIC	INTRAOCULAR LENS	HQL	ALCON RESEARCH, LTD. / HUNTINGTON	SN6AT5	10901898

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Required Intervention