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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 8065990601
Device Problem No Known Device Problem
Event Type  Injury  
Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental report will be filed as necessary in accordance with 21 cfr 803. 56 when add¿l reported info becomes available. (b)(4).

 
Event Description

A pt reports that ¿halo effect¿, post lasik surgery performed over a year ago, which makes it difficult to drive at night. Pt stated that he was reassured that this effect would go away with time, but was still experiencing it. Pt was informed by his doctor that he has large pupils, a condition which the reporter feels should have been taken into consideration by the doctor before surgery. Despite multiple attempts, to seek add¿l detail, no response was gained from the reporter. This report will reference the pt¿s right eye.

 
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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
paul nitschmann
6201 south freeway, r3-16
fort worth , TX 76134
8176152440
MDR Report Key2785713
Report Number3003288808-2012-00435
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 09/11/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/11/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number8065990601
Device Catalogue Number8065990601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received09/11/2012
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: 10/11/2012 Patient Sequence Number: 1
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