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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL VISIAN ICL

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STAAR SURGICAL VISIAN ICL Back to Search Results
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.
 
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Brand Name
VISIAN ICL
Type of Device
VISIAN ICL
Manufacturer (Section D)
STAAR SURGICAL
MDR Report Key5938957
MDR Text Key54457727
Report NumberMW5064619
Device Sequence Number1
Product Code MTA
Reporter Country CodeUS
Number of Events Reported1
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 Received09/01/2016
Type of Device Usage N
Patient Sequence Number1
Treatment
DORZOLMIDE; OTC MEDS: ZYRTEC; PRED FORTE; RX MEDS: SYNTHROID
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age41 YR
Patient Weight95
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