SEE H-10

MDR report key: 4182157 · Received October 17, 2014

Report

Report Number: 2023826-2014-00836
Event Type: Malfunction
Date Received: October 17, 2014
Date of Event: September 15, 2014
Report Date: September 19, 2014
Manufacturer: STAAR SURGICAL COMPANY
Product Code: HQL
PMA / PMN Number: P990013
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

BRAND NAME: COLLAMER®ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4). VISUAL INSPECTION SHOWED THE LENS WAS RETURNED IN LIQUID AND A SMALL TEAR BY THE HAPTIC HOLE. (B)(4)

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE 12.5 DIOPTER CC4204A COLLAMER SINGLE PIECE LENS WAS DAMAGED DURING INSERTION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER SAME MODEL LENS WITHOUT ANY PATIENT INJURY. THE REPORTER STATED THE EVENT WAS DUE TO A LOADING ERROR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
661815	SEE H-10	INTRAOCULAR LENS	HQL	STAAR SURGICAL COMPANY	CC4204A	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR			CARTRIDGE MODEL CC4204A, LOT NUMBER UNKNOWN\| FTP INDIGO MODEL, LOT NUMBER UNKNOWN\| INDIGO-P INJECTOR MODEL, LOT NUMBER UNKNOWN