MAUDE Adverse Event Report: IMPLANTABLE CONTACT LENSES

Device Problem Fitting Problem (2183)

Patient Problems Intraocular Pressure Increased (1937); Nausea (1970); Pain (1994); Loss of Vision (2139); Discomfort (2330)

Event Date 09/27/2016

Event Type  Injury  

Event Description

I received icl implantable contact lenses in both eyes, in (b)(6) 2016.Approx.A week after the second (right eye) was implanted, i started having a lot of eye pain/ pressure and reduced vision.I made a call to the doctor's office where they said to take antiinflammatories.After about an hour of those not working, i became very nauseous and we were advised to come into the office for an emergency procedure.Upon arrival, the eye surgeon on call determined the iridotomy in my right eye had closed, and i was experiencing acute angle closure.He cut into my cornea to relieve the pressure and proceeded to zap my eye with two different kinds of lasers, upwards of 30 times.My eyes have never felt the same since and although the pressure was received.The implants still needed to come out because the iris in my right eye was bowing from the fit of the lenses and causing additional pain and discomfort.They were both removed in (b)(6) 2016.Why the fda has approved these lenses, that have been shown to cause cataracts in up to 50 percent of patients, within 5 years of implant, is beyond me.

• Brand Name: IMPLANTABLE CONTACT LENSES
• Type of Device: IMPLANTABLE CONTACT LENSES
• MDR Report Key: 6961181
• MDR Text Key: 89847567
• Report Number: MW5072842
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Home Health Aide
• Type of Report: Initial
• Report Date: 10/17/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 50