VISIAN ICL (IMPLANTABLE COLLAMER LENS)

MDR report key: 2923183 · Received January 18, 2013

Report

Report Number: 2023826-2013-00060
Event Type: Malfunction
Date Received: January 18, 2013
Date of Event: July 10, 2012
Report Date: December 20, 2012
Manufacturer: STAAR SURGICAL COMPANY
Product Code: MTA
PMA / PMN Number: P030016
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

METHOD - WORK ORDER SEARCH. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF ONE HAPTIC TORN OFF. THE LENS WAS RETURNED DRY. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

Description of Event or Problem · 1

THE REPORTER INDICATED THE SURGEON INSERTED A 13.2MM VICM 13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND ANOTHER SAME MODEL WAS IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
27250	VISIAN ICL (IMPLANTABLE COLLAMER LENS)	INTRAOCULAR LENS	MTA	STAAR SURGICAL COMPANY	VICM 13.2	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	32 YR			CARTRIDGE MODEL AND LOT NUMBER UNKNOWN\| INJECTOR MODEL AND LOT NUMBER UNKNOWN