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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESTORE LENS

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RESTORE LENS Back to Search Results
Event Date 11/15/2007
Event Type  Injury  
Event Description

I had eye surgery, after my eye dr stated i would never have to wear reading glasses again. It sounded so great not to have to wear reading glasses, 2. 0 strength, that i said "count me in". He casually mentioned at the end of our conversation that only a small percent of pts experience halos -- i didn't know what he meant -- i thought angelical halos are very small, and only a small percent have problems, less than 2%, and he acted like it was no big deal --- that i bought into it. My problems started immediately after surgery -- halos around every light, each street light or car light -- over thirty feet in diameter -- multiply that by every street light and each car approaching you. Or in your rearview mirror, plus store lights, traffic lights, etc. It makes night driving extremely difficult and dangerous, and our planet earth is no longer the same! day vision is a nightmare. The glare and brightness of my world requires me to wear dark sunglasses every min i am outside, which "only" reduces the eye strain. I have to wear sun glasses while working on the computer, day and night, which is required throughout my work day and in the evening for personal use. Additionally, the sun reflects off other cars, metal roofs, and many objects as small as a soda can on the side of the road. These are piercing lights and it is impossible to avoid them while trying to drive. The lights always have several rings around them, which i assume are from the layers of the lenses --like radio waves. My most recent problems are associated with new floaters and lights within my right eye that resemble a strobe light show. When i saw my dr this week, he dilated my eye and shined bright lights in it -- he just didn't think about the impact on my retina from the brightness of them on my already challenged vision. The lights were painful and even turned green -- i thought i would have to stop the examination. I was unable to see out of that eye due to the residual affects of lights in that eye that lasted until the next day. Diagnosis: improve vision.

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Type of DeviceLENS
MDR Report Key1055501
Report NumberMW5007105
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/30/2008
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/30/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No

Date Received: 05/30/2008 Patient Sequence Number: 1