MAUDE Adverse Event Report: STAAR SURGICAL COMPANY ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS

Model Number ICM120V4

Device Problem Difficult To Position (1467)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2014

Event Type  malfunction  

Event Description

The reporter indicated the surgeon implanted a 12.0mm icm120v4 implantable collamer lens in the patient's left eye (os) on (b)(6) 2014 and due to the patient's weak zonules the lens would not stabilize in the eye.The lens kept falling backward out of the iris.The lens was removed, no patient injury reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Evaluation: method - medical review and lens work order search.Results - visual inspection of the returned product found the lens was returned dry with no visible damage.Medical review - review of this file indicates that the lens was not implanted in accordance with the dfu requirements (e.G.Patient age below 21 or over 45 years, acd below 2.8mm for icl/ticl and below 3.0mm for vicl/vticl, keratoconus, pregnant or nursing patients, patients with low/abnormal corneal endothelial cell density, fuch's dystrophy or other corneal pathology, patients who are amblyopic or blind in the fellow eye).Off-label use of the device, no clinical data can support the complaint events(s) or the effect(s) on the efficacy and safety of the device.This information has been communicated to the medical advisor of staar surgical and to the surgeon in case of severe deterioration of patient health.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-2 560; SZ CH-2560
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4337965
• MDR Text Key: 5180020
• Report Number: 2023826-2014-01125
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2016
• Device Model Number: ICM120V4
• Other Device ID Number: DIOPTER -15.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 12/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INJECTOR MODEL AND LOT NUMBER UNK; CARTRIDGE MODEL AND LOT NUMBER UNK
• Patient Age: 20 YR