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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT AG (PRESSATH) ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM

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WAVELIGHT AG (PRESSATH) ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Model Number 8065990600
Device Problem Unknown (for use when the device problem is not known)
Event Date 06/02/2006
Event Type  Injury  
Event Description

An optometrist reports a hyperopic pt with a poor clinical outcome, following bilateral lasik surgery. This report is for the right eye, the left eye was reported under mfr number 3003288808-2008-00006. At one year post-op, this pt exhibited a 1 line decrease in bcva. The pt also reported dry eye.

 
Manufacturer Narrative

Determination of root cause: assessment: the database logfile for this system was reviewed and the analysis determined the device was operating within specification during the time of this pt's surgery. Non-product factors including pt response to the laser ablation, pt healing characteristics and preoperative pt selection were reviewed. The pt presented with a non-contributory medical history and on ocular history positive for dry eye and underwent conventional spherical hyperopia lasik. The pt was noted for "loose epithelium repositioned-8. 4 scl (soft contact lens) placed" immediately after the procedure. The pt demonstrated a temp 2-line loss of bcva at the one month postoperative visit that improved to a one line loss by the 11 month visit. This may have been associated to the initial postoperative complication of loose epithelium and the pre existing condition of dry eye. (bilateral epithelial defects after laser in situ keratom ileuses. Clinical features, mgmt and outcome, srinivas rao et al, foreign journal of ophthalmology vol 53:1 p 37-42, 2005). These complications may have caused temporary and unpredictable changes in the cornea that may interfere with the ability to properly measure the refractive error and visual acuity thereby contributing to a potential loss of bcva. (refractive surgery nightmares, fahmy, hardten, chapter 35) dry eye is the most frequent complication after refractive surgery, particularly in lasik surgery, and studies indicate that dry-eye symptoms before surgery are a strong predictor of chronic dry eye after surgery. Therefore, lasik should be approached cautiously in pts with preexisting dry eye. (chronic dry eye and regression after laser in situ keratomileusis for myopia, julie m. Albietz phd et al, jour of cat and ref surg, vol 30:3, march 2003). In this case no preoperative tear assessment was documented although the pre procedure evaluation form indicated a pre existing condition of dry eye. In addition, a one line loss of bcva may not represent a true loss as it may be associated to variations in testing techniques. Conclusion: based on the results of the investigation of product and non-product factors, the device was not found to be a contributor to the decrease in bcva. However, the non-product related factors mentioned above may have been contributors.

 
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Brand NameALLEGRETTO WAVE EYE-Q
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
WAVELIGHT AG (PRESSATH)
doellnitz 5
pressath 9269 0
GERMANY 92690
Manufacturer (Section G)
WAVELIGHT AG (PRESSATH)
doellnitz 5
pressath 9269 0
GERMANY 92690
Manufacturer Contact
charles dolbee
6201 south freeway r7-18
fort worth , TX 76134
8175518317
MDR Report Key1202832
Report Number3003288808-2008-00017
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/10/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number8065990600
Device Catalogue Number8065990600
OTHER Device ID NumberPR-V2-1.00
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/28/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2005
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: 10/17/2008 Patient Sequence Number: 1
Treatment
RESTASIS
VICODIN
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