FDA Adverse Event Injury Summary report: N

VISIAN ICL (IMPLANTABLE COLLAMER LENS)

MDR report key: 1901405 · Received October 29, 2010

Report

Report Number: 2023826-2010-01090
Event Type: Injury
Date Received: October 29, 2010
Report Date: October 12, 2010
Manufacturer: STAAR SURGICAL COMPANY
Product Code: MTA
PMA / PMN Number: P030016
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION CODES: METHOD - (OTHER): LENS WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS - (OTHER): A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. MEDICAL REVIEW - ANY HIGHLY MYOPIC PATIENT HAS AN INCREASED RISK OF EXPERIENCING RETINAL TEARS AT ANY GIVEN TIME BECAUSE THE RETINA IS STRETCHED MORE AS THE MYOPIC EYES ARE LONGER. THIS ADVERSE EVENT IS MOST LIKELY SECONDARY TO THE PATIENT'S ANATOMY OF BEING HIGHLY MYOPIC RATHER THAN THE ICL ITSELF. THE CLINICAL TRIALS SHOWED THAT THE CUMULATIVE RISK OF RETINAL DETACHMENT AFTER IMPLANTATION OF THIS DEVICE IS 0.6%. CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. CLAIM # (B)(4).

Description of Event or Problem · 1

THE PATIENT REPORTED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS IN HER RIGHT EYE (OD) ON (B)(6) 2007. THE PATIENT REPORTED HAVING CRYOTHERAPY FOR MULTIPLE RETINAL TEARS. THE ICL REMAINS IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VISIAN ICL (IMPLANTABLE COLLAMER LENS)	INTRAOCULAR LENS	MTA	STAAR SURGICAL COMPANY	MICL13.2	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	INJECTOR: MODEL UNK, LOT NUMBER UNK\| CARTRIDGE: MODEL UNK, LOT NUMBER UNK\| FOAM TIP PLUNGER: MODEL UNK, LOT NUMBER UNK