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

Model Number MICL12.1

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 04/14/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lens not returned.

Event Description

The patient reported the surgeon implanted a 12.1mm micl12.1 implantable collamer lens, -13.5 diopter, in her right eye (od).The patient reported she had lost vision due to the development of a cataract (anterior and post subcapsular).The lens was explanted on (b)(6) 2014, cataract surgery was performed and an iol was implanted.The patient's va was 20/25 and the prognosis is good.

Manufacturer Narrative

Per medical review: reportedly, icl was explanted from a (b)(6) - year old patient, two years postoperatively, to address cataract development.According to completed data clarification request (dcr), received on 11/19/15, cataract was extracted and iol was implanted at the same surgery date.The same reported attributed cataract (anterior subcapsular combined with posterior subcapsular) to the device.The prognosis after secondary surgical intervention was good (va 20/25).A work order search found one similar complaint.Based on the complaint history, work order search, and medical review, a specific root cause of the event could not be determined.(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: 5328002
• MDR Text Key: 34378419
• Report Number: 2023826-2015-01751
• 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
• Report Date: 09/30/2015

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: 03/31/2014
• Device Model Number: MICL12.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2015
• Initial Date FDA Received: 12/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2012
• 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: 23 YR