MAUDE Adverse Event Report: STAAR SURGICAL VISIAN ICL

Device Problem Insufficient Information (3190)

Patient Problems Dehydration (1807); Pain (1994); Visual Impairment (2138); Vomiting (2144)

Event Date 08/10/2016

Event Type  Injury  

Event Description

I went in for a "busy" and icl on both eyes on (b)(6) 2016.On (b)(6) 2016, i awoke in excruciating pain and was unable to see out of one eye.I was directed to two different doctors offices and then finally an emergency room in (b)(6) and then admitted into (b)(6) hospital.They performed a surgical iridotomy in my left eye to release the pressure that went up to 62 and my left eye.I was lasered dozens of time trying to release the pressure.The pain was excruciating.I couldn't keep food down.I was vomiting every 15 minutes.I could not be in late.I was dehydrated.After the surgery on (b)(6) i was released from the hospital on (b)(6).I was scheduled to return back to (b)(6) hospital in (b)(6) for procedure but it was too painful to be done.I returned back to my ophthalmologist and then a glaucoma specialist and they were treating me twice a week for a couple of weeks.I am currently seeing about 20/60 in my left eye and i'm not in as much pain.The doctors are still waiting to see if the lens will have to be removed, or if my vision will just be impaired.My vision in my right eye does not allow me to see things close up.The doctors are saying that i need to wear reading glasses which defeats the whole purpose of getting the busy and icl so that you do not need glasses.On prior to the surgery, i was seeing fine with my contacts never needed reading glasses.

• Brand Name: VISIAN ICL
• Type of Device: VISIAN ICL
• Manufacturer (Section D): STAAR SURGICAL
• MDR Report Key: 5938957
• MDR Text Key: 54457727
• Report Number: MW5064619
• Device Sequence Number: 1
• Product Code: MTA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/01/2016

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DORZOLMIDE; OTC MEDS: ZYRTEC; PRED FORTE; RX MEDS: SYNTHROID
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 95