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

Model Number MICL12.6

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cataract, Induced (1767); Loss of Vision (2139)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lens implanted.

Event Description

The patient reported the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -8.5 diopter, in his left eye (os).The patient reported his vision has changed to -0.5.The facility reported the patient has an early cataract, due to the aging process and not related to the device.The lens remains implanted.The patient's post-op va was 20/25.

Manufacturer Narrative

Method: medical review, work order search results: per medical review: on (b)(6) 2015 the patient completed 36 month post-treatment patient follow-up form and reported decrease of visual acuity following icl implantation.According to dcr form, received on 11/19/15, the cause of the event was a cataract development due to aging process and not related to the device.Icl remained implanted and ucva was 20/25 with good prognosis.Seriousness is based on no reported loss of bcva and no report of any secondary intervention planned or scheduled.It should be noted that at the time of the icl implantation patient was (b)(6) and per dfu indications: "the visian icl is indicated for use in adults 21-45 years of age", therefore there is no sufficient safety and effectiveness data to support implantation in such patients.Furthermore, literature reports that only 1-2% of patients develop clinically significant cataract following icl implantation probably due to patient related factors (especially high myopes and older patients).A work order search found no similar complaints.Claim #(b)(4).

Manufacturer Narrative

(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-25 60; SZ CH-2560
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5328083
• MDR Text Key: 34379782
• Report Number: 2023826-2015-01750
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,study
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2015

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: 01/31/2014
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2015
• Initial Date FDA Received: 12/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/16/2016; 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2012
• 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
• Patient Age: 52 YR