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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 LASER EXCIMER LASER SYSTEM

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ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 LASER EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065490006
Device Problem Unknown (for use when the device problem is not known)
Event Date 10/20/2008
Event Type  Injury  
Event Description

A surgeon reports a patient with an undercorrection in the left eye following lasik surgery. Patient records were received and showed the patient experienced a 1-line decrease in bcva. Approximately 2. 5 months post-op, a corneal flap-lift was performed with epithelial scrape and refloat to address epithelial ingrowth that was present over the central portion of the eye. The surgeon stated the patient was not harmed/injured and the 1-line decrease in bcva is temporary.

 
Manufacturer Narrative

Determination of root cause: assessment: a surgery database performance verification was conducted on this system and the analysis determined the laser performance factors analyzed were operating within specification during the time of this patient's surgery. Non-product factors including patient response to the laser ablation, patient healing characteristics and preoperative patient selection were reviewed. This patient presented with a non-contributory medical and ocular history and received an uneventful myopia with astigmatism lasik procedure. During the 6 weeks post-operative period, the patient demonstrated variable ucvas, and similar manifest refractions (mr) and bcvas. The patient was diagnosed with postoperative dry eyes, "irregular epithelium" and "small islands of epithelial ingrowth". Approximately 2. 5 months post-op, the corneal flap was "1/2 lifted" and "epith scrape and refloat" was performed. The slit lamp examination (sle) demonstrated central "flap edema - and central staining. During the 2 week post-refloat period, the patient demonstrated changes in ucva with the final one reported as 20/25 and the sle noted "old, no active oz". No mr or bcva were recorded. The patient also experienced a 1-line decrease in bcva, 20/15 pre-op to 20/20 post-op. Further communication with the surgeon indicated he feels a 1 line decrease of bcva is only temporary and the technician probably did not push the patient to try the 20/15 line (differences in testing techniques). He also indicated that the patient was not harmed or injured by the reported event. During the post-operative period, the patient demonstrated variations in the ucva and bcva indicating the possibility that the postoperative refractive state may not have stabilized, therefore, providing an inaccurate measurement of the residual refractive error and bcva. (regression and its mechanism after lasik in moderate and high myopia, chayet et al, ophthalmology, vol 105:7, july 1998 p. 1194-1199) the usual period for healing and vision/refractive stabilization after refractive surgery is one to 3 months. (aao. Org, refractive laser sx: an in depth look at lasik, a science writers guide, may 2008). The patient was noted for postoperative dry eye. Dry eye may cause temporary and unpredictable changes in the cornea that may interfere with the ability to properly measure the refractive error and or visual acuity, thereby contributing to a potential decrease of bcva (refractive surgery nightmares, fahmy, hardten, chapter 35) and to the reported undercorrection. The 1-line decrease of bcva may also have been associated to the postoperative complication of "irregular epithelium", the "small epithelial ingrowth" and to the dry eye. Although not always serious, epithelia ingrowth may cause epithelial irregularity, threatening to reduce vision. Epithelial ingrowth is a condition where corneal epithelial cells, invade and grow underneath the corneal flap created in lasik, possibly due to poor blade quality, improper positioning of the flap or a gap between the stromal bed and the flap. If signs of proliferation exist, re-lifting of the flap and irrigation and removal of the cells is indicated to prevent major corneal complications. (rates of epithelial ingrowth after lasik for different excimer laser systems, roo et al, j of ref surg, vol 21:3, p 276-280, may/june 2005) (epithelial ingrowth after laser in situ keratomileusis, wang and maloney, am j of oph vol 129:6 june 2000 p. 746-751). 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 patient's outcome. However, the non-product related factors mentioned above may have been contributors.

 
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Brand NameLADARVISION 4000 LASER
Type of DeviceEXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery drive
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery drive
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway r7-18
fort worth , TX 76134
8175518317
MDR Report Key1312323
Report Number1061857-2009-00002
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 11/06/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/12/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8065490006
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/13/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2001
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: 02/12/2009 Patient Sequence Number: 1
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