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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLEGRO WAVELENGTH LASER; LASIK EYE SURGERY
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ALLEGRO WAVELENGTH LASER; LASIK EYE SURGERY Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)
Patient Problems Dry Eye(s) (1814); Emotional Changes (1831); Eye Injury (1845); Pain (1994); Discomfort (2330); Disability (2371)
Event Date 09/05/2013
Event Type  Injury  
Event Description
Patient called to report adverse events after receiving lasik eye surgery with an allegro wavelength laser on (b)(6) 2013, in both eyes.Patient stated prior to the procedure, he had no issues with his eyes.He said around (b)(6) 2013, after the procedure, he started to have extreme, severe dry eye issues that were extremely painful.He also explained that he can't keep his eyes open and that his eyes feel like they are being pulled forward.He is extremely upset with his current condition and said he hasn't been able to work since (b)(6) 2013.Patient said he has seen 3 ophthalmologists and spent $(b)(4) trying to correct the adverse reactions.He said it's difficult for him to function.Patient explained he was told that his condition is chronic and he is worried about his future, he feels disabled.He said he has contemplated suicide and is talking to a therapist.He said his pain is so bad that everyday he lives in torment, and that he may not be around very much longer to see if his condition ever improves.The patient was transferred to local (b)(4) crisis prevention hotline.
 
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Brand Name
ALLEGRO WAVELENGTH LASER
Type of Device
LASIK EYE SURGERY
MDR Report Key3518657
MDR Text Key17618188
Report NumberMW5033315
Device Sequence Number1
Product Code LZS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/11/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Is the Reporter a Health Professional? No
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
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