FDA Adverse Event Injury Summary report: N

VISIAN ICL (IMPLANTABLE COLLAMER LENS)

MDR report key: 1840873 · Received September 16, 2010

Report

Report Number: 2023826-2010-00928
Event Type: Injury
Date Received: September 16, 2010
Date of Event: August 20, 2010
Report Date: August 20, 2010
Manufacturer: STAAR SURGICAL CO.
Product Code: MTA
PMA / PMN Number: P030016
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): EVALUATION RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. MEDICAL REVIEW - "TOXIC ANTERIOR SEGMENT SYNDROME" (TASS) PRESENTS WITH POSTOPERATIVE INFLAMMATION WITH NO OBVIOUS CAUSE. TASS IS COMMONLY DUE TO NONPHYSIOLOGIC FACTORS AND ARE OFTEN THE RESULT OF PATIENT'S REACTION TO ABNORMAL SOLUTIONS, CONTAMINATION OF EQUIPMENT, AND /OR IOLS. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED; (B)(4).

Description of Event or Problem · 1

THE REPORTER STATED THE SURGEON INSERTED A MICL 13.2MM IMPLANTABLE COLLAMER LENS ON (B)(6)2010 IN THE PATIENT'S LEFT EYE. THE PATIENT DEVELOPED TOXIC ANTERIOR SEGMENT SYNDROME, INCLUDING INCREASED CELLS AND FLARES. THE ANTERIOR CHAMBER TAP WAS STERILE. AN ANTERIOR CHAMBER WASH WAS DONE AND PATIENT WAS STARTED ON FORTIFIED ANTIBIOTIC DROPS PLUS STEROIDS. AFTER FOUR DAYS TASS WAS RESOLVED AND PATIENT'S CURRENT BVCA IS 20/20. LENS REMAINS IMPLANTED. SEE MFR #2023826-2010-00927 FOR THE RIGHT EYE.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	20 YR		Required Intervention	FORM TIP PLUNGER: MODEL AND LOT NUMBER UNK\| INJECTOR: MODEL MSI-PF AND LOT NUMBER UNK\| CARTRIDGE: MODEL SFC-45 FP AND LOT NUMBER UNK