ORBSCAN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-10-09 for ORBSCAN manufactured by .

Event Text Entries

[21649572] I had my annual eye exam on (b)(6) 2010. I was seeing very well with my contacts but decided to see if i was a candidate for lasik surgery. I scheduled an appointment the next saturday - (b)(6) 2010 for the free consultation and screening exam with (b)(6) in (b)(6). I had several different orbscans performed by technicians. Some of the tests were repeated a few times to get the correct result. Dr (b)(6) dilated my eyes and performed a few more tests. She then advised me that i would be a good candidate for the lasik surgery and went over the costs, etc. She then placed reverse-dilatation eye drops in my eyes and i left icon lasik with my sunglasses on. It wasn't more than about 10 minutes after i left icon lasik that i noticed that i wasn't seeing well for my reading in my right eye-the eye i use for reading with my monovision contacts. When reading, it was very blurry in the middle and i was seeing some residual flashing lights off and on like what was used in the orbscans. Since the lasik center was now closed, i made 2 calls during the week of (b)(6) 2010 and spoke with dr (b)(6) who said that she didn't do anything invasive which could have caused any damage. My vision has not been the same since. She told me, it was a coincidence that it happened.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5017739
MDR Report Key1876071
Date Received2010-10-09
Date of Report2010-10-09
Date of Event2010-09-25
Date Added to Maude2010-11-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Generic NameORBSCAN
Product CodeMXK
Date Received2010-10-09
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2010-10-09

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