FDA Adverse Event Malfunction Summary report: N

COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

MDR report key: 1120023 · Received August 14, 2008

Report

Report Number: 2023826-2008-01070
Event Type: Malfunction
Date Received: August 14, 2008
Date of Event: June 5, 2008
Report Date: July 28, 2008
Manufacturer: STAAR SURGICAL COMPANY
Product Code: HQL
PMA / PMN Number: P990013
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN. PIECES OF THE LENS OPTIC AND ONE HAPTIC WERE TORN OFF. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION. CONCLUSIONS - A MULTIFUNCTIONAL TEAM INVESTIGATED COMPLAINTS REGARDING LENS TEARS ASSOCIATED WITH THE CQ CARTRIDGE: THE RESULTANT CORRECTIVE ACTIONS INCLUDED IMPROVEMENTS IN MANUFACTURING, RELEASE TESTING, AND EVALUATION OF TEST RESULTS. ADDITIONALLY, THE INJECTOR/CARTRIDGE DIRECTIONS FOR USE (DFU) HAVE BEEN MODIFIED TO ADD FURTHER CLARIFICATIONS TO INSTRUCT THE USERS IN THE PROPER DELIVERY TECHNIQUES THAT ARE EFFECTIVE, AND MINIMIZE THE POTENTIAL FOR DAMAGING THE LENS.

Description of Event or Problem · 1

THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS AND THE HAPTIC TORE. THE LENS WAS REMOVED WITH NO REPORT OF ANY PATIENT INJURY. ANOTHER SAME TYPE LENS WAS INSERTED BUT THIS LENS ALSO TORE - SEE MFR REPORT # 2023826-2008-01071. A THIRD DIFFERENT TYPE LENS WAS IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA	INTRAOCULAR LENS	HQL	STAAR SURGICAL COMPANY	CQ2015A	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1				CARTRIDGE MOEDL: CQ CARTRIDGE-FP\| INJECTOR MODEL: MSI-PM