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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM

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WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Model Number 8065990631
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Manufacturer Narrative

Investigation, including root cause analysis, is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).

 
Event Description

Surgeon reported that a pt was not satisfied with surgery results and is complaining that they see badly in the dark with opened pupil (8. 7-8. 8 mm). Entries in medical record indicate pt refused to use cholinergic eye drops. Surgeon also reporting pt has also complained about dry eye, however pt was recommended to use eye drops but refused any treatment. It was indicated that the surgeon detected anisometropia during the pt's last visit, however the pt refused an additional correction offered by the clinic specialists. The surgeon also reported pt is now having suicidal thoughts. This report references the left eye. The right eye, of the same pt, will be reported separately. Additional information has been requested.

 
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Brand NameALLEGRETTO WAVE EYE-Q
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
WAVELIGHT GMBH
am wolfsmantel 5
erlangen 9105 8
GERMANY 91058
Manufacturer (Section G)
WAVELIGHT GMBH
am wolfsmantel 5
erlangen 9105 8
GERMANY 91058
Manufacturer Contact
cynthia kay
6201 south freeway, r3-48
fort worth , TX 76134
8176152605
MDR Report Key3370307
Report Number3003288808-2013-00517
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 08/15/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number8065990631
Device Catalogue Number8065990631
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/15/2013
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/11/2013 Patient Sequence Number: 1
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