SEE H-10

MDR report key: 2842671 · Received November 21, 2012

Report

Report Number: 2023826-2012-00934
Event Type: Malfunction
Date Received: November 21, 2012
Date of Event: August 16, 2012
Report Date: October 25, 2012
Manufacturer: STAAR SURGICAL COMPANY
Product Code: HQL
PMA / PMN Number: P990013
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CE
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PATIENT WEIGHT - UNK. COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4).

Additional Manufacturer Narrative · 1

METHOD: WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS TORN INTO TWO PIECES, FROM ONE HAPTIC THROUGH THE LENS OPTIC TO THE OTHER HAPTIC. THE LENS WAS RETURNED DRY AND THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING PROCESS OF THIS LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW 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 CC4204BF COLLAMER SINGLE PIECE LENS AND THE LENS WAS NOTED TO BE TORN. THE LENS WAS REMOVED WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SEE H-10	INTRAOCULAR LENS	HQL	STAAR SURGICAL COMPANY	CC4204BF	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR			INJECTOR MODEL AND LOT NUMBER UNK\| CARTRIDGE MODEL AND LOT NUMBER UNK