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

Model Number MICL12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cataract (1766); Loss of Vision (2139); No Code Available (3191)

Event Date 09/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: lens work order search results: a lens work order search was performed and no similar complaints were found.Conclusion: based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).

Event Description

The patient reported the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -11.0 diopter, in his left eye (os).The patient reported had lost vision due to the development of a cataract.The lens was explanted and replaced.The lens was implanted on (b)(6) 2011.The facility reported they confirmed the patients report.The date of cataract diagnosis was (b)(6) 2015 and it was an anterior subcapsular cataract.The lens was explanted on (b)(6) 2015, cataract surgery was performed and an iol was implanted.The patient's post-op va was 20/25.The facility reported the event was related to the device.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6358993
• MDR Text Key: 68348997
• Report Number: 2023826-2017-00252
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/21/2016

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: 08/31/2012
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2010
• 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: 44 YR