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

Model Number MICL13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problems Cataract, Induced (1767); Loss of Vision (2139); No Code Available (3191)

Event Date 07/21/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lens not returned.

Event Description

The patient reported the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -8.0 diopter, in her left eye (os).The patient reported she had lost vision due to the development of a cataract (anterior subcapsular).The lens had a low vault.The lens was explanted on (b)(6) 2015, the cataract was removed and an iol was implanted.The patient's post-op va was 20/20.

Manufacturer Narrative

Method: medical review, work order search.Results: per medical review: reportedly icl was explanted 3 years postoperatively to address low vault and a cataract development.According to completed data clarification request, dated on (b)(6) 2015, the type of cataract was anterior subcapsular and was attributed to the device.Following icl removal, cataract was extracted, and iol was successfully implanted.The same report stated that the patient prognosis was good (va:20/20).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 and that was reflected in device causality.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 similiar complaints.Conclusion: based on the complaint history, work order search, and medical review, a specific root cause of the event could not be determined.(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: 5327964
• MDR Text Key: 34378206
• Report Number: 2023826-2015-01752
• 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: 05/26/2015

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: 12/31/2013
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 12/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/16/2016; 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR