FDA Adverse Event Malfunction Summary report: N

COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

MDR report key: 1052898 · Received May 22, 2008

Report

Report Number: 2023826-2008-00679
Event Type: Malfunction
Date Received: May 22, 2008
Date of Event: April 14, 2008
Report Date: April 23, 2008
Manufacturer: STAAR SURGICAL CO.
Product Code: HQL
PMA / PMN Number: P990013
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVAL CODES: CONCLUSION: AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN JUNE 2005. THE DAMAGE TO THE LENS, AS OBSERVED AND PHOTOGRAPHED UPON THE RETURN OF THE LENS TO STAAR, CAN NOT BE DEFINITIVELY AND EXCLUSIVELY CORRELATED TO A SPECIFIC ROOT CAUSE. POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND POSSIBLE HANDLING ERRORS BY THE CUSTOMER. TO ADDRESS DELIVERY SYSTEM ISSUES, ALL STAGES IN THE MANUFACTURING OF THE INJECTORS AND CARTRIDGES WERE REVIEWED AND REVISED AS OPPORTUNITIES FOR IMPROVEMENT WERE REVEALED. TO ADDRESS HANDLING ERRORS, ALL 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

IT WAS REPORTED THAT THE SURGEON INSERTED CC4204BF COLLAMER PLATE LENS AND A HAPTIC TORE OFF UPON INSERTION. THE LENS WAS REMOVED WITHOUT ANY PT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL	INTRAOCULAR LENS	HQL	STAAR SURGICAL CO.	CC4204BF	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			FTP INDIGO MODEL\| CARTRIDGE MODEL SFC-45 FP\| INJECTOR MODEL INDIGO-P