VISIAN ICL (IMPLANTABLE COLLAMER LENS)

Report

Report Number: 2023826-2012-00840
Event Type: Injury
Date Received: October 24, 2012
Date of Event: February 16, 2012
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: THE ICL IS INDICATED IN PATIENTS 21-45 YEARS OF AGE. THERE IS A MUCH GREATER RISK OF CATARACT IN PATIENTS OVER 45 YEARS OF AGE POST ICL IMPLANTATION. THE PATIENT IN THIS CASE IS (B)(6) OF AGE. 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 THESE CASES AND VISUAL OUTCOME WAS GOOD. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4). 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 MICL12.1 IMPLANTABLE COLLAMER LENS ON (B)(6) 2011 AND A CATARACT WAS NOTED ON (B)(6) 2012. PATIENT HAD TR CS PRE ON (B)(6) 2011. THE LENS WAS REMOVED ON (B)(6) 2012 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	54 YR		Required Intervention