FDA Adverse Event Injury Summary report: N

VISIAN ICL (IMPLANTABLE COLLAMER LENS)

MDR report key: 2802910 · Received October 24, 2012

Report

Report Number: 2023826-2012-00841
Event Type: Injury
Date Received: October 24, 2012
Date of Event: September 11, 2010
Report Date: September 24, 2012
Manufacturer: STAAR SURGICAL COMPANY
Product Code: MTA
PMA / PMN Number: P030016
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

METHOD: MEDICAL REVIEW. RESULTS: ANTERIOR SUBCAPSULAR CATARACT IS A LABELED COMPLICATION IN THE IMPLANTATION OF AN ICL. CATARACT EXTRACTION MAY BE NECESSARY IF VISION IS COMPROMISED, TO PRECLUDE INCREASE IN SEVERITY OF THE CONDITION. IF THE CONDITION IS NON-PROGRESSIVE, THE SURGEON MAY OPT TO LEAVE THE ICL, ESPECIALLY WHEN THERE IS NO DECREASE IN VISUAL ACUITY. IN THE U.S. FDA CLINICAL TRIALS, APPROXIMATELY 6% TO 7% OF EYES DEVELOPED ANTERIOR SUBCAPSULAR OPACITIES AT 7 YEARS FOLLOWING ICL IMPLANTATION, BUT ONLY 1%-2% PROGRESSED TO CLINICALLY SIGNIFICANT CATARACT DURING THE SAME PERIOD. CATARACT EXTRACTION WAS PERFORMED IN THIS CASE WHICH RESOLVED THE PROBLEM. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4) - CATARACT, SURGICAL PROCEDURE, EXPLANTED. EVALUATION METHOD - A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND WITHIN THE WORK ORDER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE SURGEON INSERTED THE MICL12.6 IMPLANTABLE COLLAMER LENS ON (B)(6) 2008 AND A CATARACT WAS NOTED ON (B)(6) 2010. THE LENS WAS REMOVED ON (B)(6) 2010 AND REPLACED WITH AN IOL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VISIAN ICL (IMPLANTABLE COLLAMER LENS)	INTRAOCULAR LENS	MTA	STAAR SURGICAL COMPANY	MICL12.1	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	28 YR		Required Intervention