FDA Adverse Event Injury Summary report: N

SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC

MDR report key: 729293 · Received June 26, 2006

Report

Report Number: 2023826-2006-00897
Event Type: Injury
Date Received: June 26, 2006
Date of Event: May 16, 2006
Report Date: June 1, 2006
Manufacturer: STAAR SURGICAL COMPANY
Product Code: HQL
PMA / PMN Number: P880091
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT ONE LENS HAPTIC WAS TORN OFF AND A PORTION OF THE OTHER LENS HAPTIC WAS MISSING AND WAS FOUND STUCK IN THE MTC-60C FP CARTRIDGE AND THE LENS OPTIC IS TORN OFF AND A PORTION OF THE OTHER LENS HAPTIC WAS MISSING AND WAS FOUND STUCK IN THE MTC-60C FP CARTRIDGE SHOWS THAT THERE IS NO VISIBLE DAMAGE. CLEAR SURGICAL AND REDDISH RESIDUE/DEBRIS ON THE PRODUCT. CONCLUSION- (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND EVALUATION FO THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR WAS NOT RETURNED FOR EVALUATION. PMA# IS P880091

Description of Event or Problem · 1

THE REPORTER STATED THAT THE SURGEON INSERTED A AA4203TL SINGLE PIECE SILICONE LENS WITH TORIC OPTIC. THE LENS TORE UPON INSERTION INTO THE EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND REQUIRED A SUTURE TO CLOSE THE WOUND. THE CAUSE OF THE LENS TEARING WAS DUE TO THE WAY THE LENS WAS LOADED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC	INTRAOCULAR LENS	HQL	STAAR SURGICAL COMPANY	AA4203TL	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Required Intervention	CARTRIDGE MODEL MTC-60C FP, LOT #1180725\| INJECTOR MODEL MSI-PR, LOT # UNK