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

Model Number ICM120V4

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 08/07/2014

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.0mm icm120v4 implantable collamer lens in the patient's right eye (od) on (b)(6) 2014 and the lens was explanted on (b)(6) 2014 due to malposition of the lens.The icl fell behind the sulcus without being tucked on the sulcus.No lens contact.See mfr# 2023826-2014-01015 for the other eye.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Method: lens work order search & medical review.Results: visual inspection of the returned product showed the lens was returned dry and there was no visible damage.The lens was re-hydrated and both the width and length were remeasured and found to be within original design specifications.Medical review - zonular weakness is present is some eye conditions including marfan's syndrome, after ocular trauma, and high myopia with large axial length.If there is a significant area zonular weakness the icl may dislocate.Preoperative assessment may show ocular signs of potential zonular weakness (phacodonesis, bulging or dislocation of crystalline lens, etc).The most probable cause of the event was a patient's condition.(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: 4274795
• MDR Text Key: 5007094
• Report Number: 2023826-2014-01016
• 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: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2016
• Device Model Number: ICM120V4
• Other Device ID Number: DIOPTER -17.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 11/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2013
• 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: CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR