FDA Adverse Event Injury Summary report: N

ACRYSOF

MDR report key: 2894762 · Received December 20, 2012

Report

Report Number: 9612169-2012-00100
Event Type: Injury
Date Received: December 20, 2012
Date of Event: October 31, 2012
Report Date: November 20, 2012
Manufacturer: ALCON LABORATORIES IRELAND LTD.
Product Code: HQL
PMA / PMN Number: P930014
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: DA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS OBSERVED. THE LENS HAD DRIED SOLUTION AND THE OPTIC WAS TORN/SPLIT (POSSIBLY CUT) AND WAS SCRATCHED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. DUE TO THE CONDITION OF THE RETURNED LENS, THE DAMAGE IS MOST LIKELY CAUSED BY THE CUSTOMER AND IT IS UNLIKELY THAT THE DEVICE CONTRIBUTED TO THE EVENT. THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS LOT. INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

Description of Event or Problem · 1

A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE SURGEON NOTED A SCRATCH SHAPED LIKE A STAR IN THE LENS OPTIC. THE IOL WAS REPLACED WITH A SAME MODEL LENS DURING THE SAME SURGICAL PROCEDURE. THE INCISION WAS ENLARGED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO REPORTED THAT THE VISUAL ACUITY WAS "NOT CONTROLLED" [VISUAL ACUITY REDUCED]. HE INDICATED THE EVENT CONTINUES AND THE OUTCOME IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACRYSOF	INTRAOCULAR LENS	HQL	ALCON LABORATORIES IRELAND LTD.	SN60WF	20922757

Patients

Seq	Age	Sex	Outcome	Treatment
1	86 YR		Other	UNKNOWN VISCOELASTIC\| MONARCH D CARTRIDGE