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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 8065990601
Device Problem No code available
Event Date 08/23/2009
Event Type  Injury  
Event Description

Adverse events: induced astigmatism. Decreased bcva. A surgeon reports a pt with an asymmetric lasik treatment in the right eye; the superior part of the corneal ablation seems to be flatter in comparison to the inferior per the pt's topography. The surgeon indicated this pt was not harmed or injured, but wanted to send in pt records for a review and feedback. Pt records were received and reviewed. Pre-operative topography showed some irregularity or symmetry in the topographical profiles. This observation was shared with the surgeon during a f/u discussion. The surgeon acknowledged the pre-operative irregularity, but found that to be normal. The pt also experienced a decrease in bcva and induced astigmatism post-operatively; however, the surgeon again stated there were no concern of harm or injury for this pt, the decrease in bcva was temporary and individual pt response to the treatment may have been a factor in this case. Although requested, no add'l pt records were provided.

 
Manufacturer Narrative

Determination of root cause: assessment: during the on-site visit, the territory manager verified the system and concluded it was functioning per product specifications. A log file review of the date of this pt's surgery indicated all laser functions were within specifications during the pt's surgery. The complaint database was reviewed for the previous 12 months and did not reveal any similar complaints for this laser system. Non-product factors including pt response to the laser ablation, pt healing characteristics and preoperative pt selection were reviewed. Clinical findings - the pt presented with a non contributory medical or ocular history. The uncorrected visual acuity (ucva) was 20/100, the manifest refraction (mr) was -0. 75-2. 2-5x91, the best corrected visual acuity (bcva) was 20/20, and on (b) (6) 2009 underwent myopia with astigmatism lasik with a treatment plan of -1. 00-2. 00x091. During the 2. 5 months postoperative period, the pt demonstrated similar ucvas and mrs with variable bcvas. The final measurements were reported as 20/80, +0. 50-3. 25x007 (cycloplegic refraction) and 20/30 respectively. The pt was using restasis throughout the 2. 5 months postoperative period bid. Pre operative and postoperative orbscans were provided. Induced astigmatism refers to the presence of post-operative astigmatism greater than the amount present pre-operatively or now present in the opposite axis. The severity of the induced astigmatism is determined by the magnitude as reported in the investigation and in this case it was determined to be serious. In this case the preoperative orbscan measurement showed mild corneal asymmetry with a steeper inferior curvature as compared to the superior curvature. In addition, this preoperative orbscan measurement appeared to be slightly temporally decentered, with an apparent mild irregular astigmatism. These same observations were noted in the postoperative maps. Minimal inconsistencies in angle kappa in all topographies were also observed, that may have contributed to a possibly incorrect judgement of centration (1) (2), and thereby contributing to the unexpected outcome. The pt was using restasis which is indicated to increase tear production in patients whose tear product is presumed to be suppressed due to ocular inflammation associated with dry eyes (3). Dry eye may cause temporary and unpredictable changes in the cornea that may interfere with the ability to properly measure the refractive error/visual acuity, possibly contributing to variations in ucva, mr and loss of bcva (4). The pt demonstrated in apparent 2 lines loss of bcva, that according to the doctor, did not represent any harm or injury as it was temporary in nature. References: utilizing new-technology iols to deliver best pt outcomes, (b) (6), annual meeting, cataract & refractive surgery today, (b) (6) md, moderator. Preoperative prediction of intraocular lens decentration: exploring angle kappa. (b) (6), (b) (6) xxv congress of the (b) (6) 8-12 sept 2007. Rxlist, restasis, the internet drug index. Refractive surgery nightmares, fahmy, hardten, chapter 35. Conclusion: based on the results of the investigation of product and non-product factors, the device was not found to be contributor to the pt's outcome. However, the non-product related factors mentioned above may have been contributors. (b) (4).

 
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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 Key1600416
Report Number3003288808-2010-00003
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/30/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number8065990601
Device Catalogue Number8065990601
OTHER Device ID NumberPR V4 1.02
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/30/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2008
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: 02/09/2010 Patient Sequence Number: 1
Treatment
LISINOPRIL 10 MG DAILY
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