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

Model Number MICL12.6

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

Patient Problems Cataract (1766); Inflammation (1932); Loss of Vision (2139)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported the surgeon implanted a micl12.6 implantable collamer lens, -13.5 diopter, in the left eye (os).The patient reported had lost vision due to the development of a cataract and was prescribed oral medications or eye drops for at least 3 consecutive months due to inside of eye was inflamed.Information received from the facility confirmed the patient report and the date of the cataract diagnosis was (b)(6) 2016.They indicated patient has episcleritis externally which required pred forte to clear.The icl remains implanted.

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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6305835
• MDR Text Key: 66656116
• Report Number: 2023826-2017-00223
• 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: 07/19/2016

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: 11/30/2013
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 02/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2011
• 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 # - UNK; INJECTOR MODEL AND LOT # - UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR