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Model Number 8065990600
Device Problem Device Displays Incorrect Message
Event Date 08/20/2009
Event Type  Injury  
Event Description

Adverse events: induced astigmatism. Decrease in bcva. Malfunction: system error message. A surgeon reported they received a secondary energy error that interrupted a surgical procedure in progress at 29% completion. The system was rebooted to resolve this error. Upon rebooting they then received an error 8: scanner defective message when they tried to arm the laser. The facility rebooted again, but this did not resolve the error when trying to arm. A monthly scanner test was performed and then another reboot was attempted. The issue then resolved and they were able to complete the surgery. Additional information was received. At three weeks following surgery this patient had induced astigmatism in the left eye (reported as an overcorrection of the astigmatic component) and a decrease of six lines of bcva. At this the postoperative refractions are reported as being unstable which could be due to some underlying edema and corneal surface changes; the patient may need some additional time to heal. At 4 weeks post op the bcva improved to 20/30, a 2 line decrease. The surgeon discussed the patient's details with alcon's medical monitor. After discussion of outcome and postoperative stage, the surgeon notified alcon that he felt the patient was not harmed or injured, the decrease in bcva was temporary and he expected the patient to heal.

Manufacturer Narrative

Determination of root cause: assessment: during the on-site investigation, the territory manager (tm) could not duplicate the scanner problem reported by the customer. However, the error was found several times in the log file. The tm tested the scanner by running several test surgeries with no failures as well as running standard scanner tests several times. The tm replaced the scanner assembly as a preventive measure. While investigating the energy too low message, the tm found the laser head was not producing enough energy and the laser head was replaced. The tm aligned and verified the system to specification following the work performed. A review of the complaint database for the last 3 months for both the scanner issue and low energy message revealed no other complaints reported for this laser system. The surgeon provided patient records. Following a consultation with alcon's medical monitor regarding patient status, the surgeon stated he does not feel the patient suffered harm or injury and considered the decrease in bcva to be temporary. Clinical findings- the patient presented to the clinic with an ocular history positive for contact lens (ctl) wear, and an indication of the lenses being out for 2 days prior to the preoperative visit. The patient also was noted for having a (b) (6) baby. The uncorrected visual acuity (ucva) was counting fingers (cf), and the manifest refraction (mr) and best corrected visual acuity (bcva) were -8. 25-0. 75x165, 20/20. One black and white and one colored orbscan preoperative measurements were provided for (b) (6) 2009 and (b) (6) 2009 respectively. On (b) (6) 2009, the patient underwent myopia with astigmatism lasik. During the one month postoperative period the patient demonstrated variable ucvas, and variable residual refractive errors and bcvas, with the final ones reported as, 20/60, +0. 75-2. 00x075, and 20/30 respectively. During that time the slit lamp exam (sle) was noted for edema, "os>od". Surgeon's notes indicated "it's too soon to retreat, will wait till it's stable". In this case, and as reported by the surgeon, the patient demonstrated a temporary 2 lines loss of bcva. The term best corrected visual acuity [bcva] describes the highest measurable level of visual acuity based upon subjective responses with the aide of a corrective optical device. A loss of bcva after refractive surgery indicates that the postoperative bcva is less than the preoperative bcva. The severity is determined by the magnitude as found in the investigation, based upon the number of lines lost on the standard acuity chart. In this case the severity was determined to be serious. Nonetheless, the surgeon reported that the patient was not harmed or injured and the decrease in bcva was temporary. The patient demonstrated a temporary 6 lines loss of bcva at the 3 weeks postoperative visit that improved to a 2 lines loss by the one month visit. At that early time during the healing process the refractive state may not have stabilized; therefore, providing an inaccurate measurement of the residual refractive error and bcva. The patient demonstrated unstable refractions during the reported postoperative period. The usual period for healing and vision/corneal stabilization after refractive surgery may take up to 3 months. Sle demonstrated corneal edema, a condition that may have also contributed to the reported loss of bcva and residual refractive error. Pre operative measurements were taken after the patient was 2 days off ctl. There was no indication of type of ctl, (soft, hard, toric, daily or extended wear) and no evidence of refractive and corneal stability after ctl removal. De-adaptation from a contact lens is necessary to allow the cornea and refractive state to stabilize providing an accurate measurement preoperatively, in order to develop an accurate treatment plan. This de-adaptation time also depends on the type of ctl, and should be followed by two week interval checkups to assess the corneal stability, before laser surgery can be considered. In this case, although preoperative orbscan measurements were difficult to compare due to one being black and white and the other one in color, some variations were observed, possibly indicating a potential unstable cornea. The patient was noted having a (b) (6) baby, and according to some surgeons, there is a possibility of corneal/refractive instability due to hormones produced during pregnancy, that may have lead/contributed to inaccuracies in the preoperative measurements. The patient demonstrated induced astigmatism that may have also been associated to the non-product factors mentioned above. The surgeon discussed the event with the medical monitor who agreed with the findings exposed above, provided him with some advice on reviewing his surgical nomogram and presented him options on how to proceed. The surgeon agreed with the medical monitor. Conclusion: based on the results of the investigation of product and non product factors, it appears that both the device and non product factors mentioned above may have been contributors. (b) (4). (b) (4).

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Manufacturer (Section D)
doellnitz 5
pressath 9269 0
GM  92690
Manufacturer (Section G)
doellnitz 5
pressath 9269 0
GM  92690
Manufacturer Contact
charles dolbee
6201 south freeway, r7-18
fort worth , TX 76134
MDR Report Key1600414
Report Number3003288808-2010-00005
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/20/2009
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? Yes
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 Received09/14/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Date Received: 02/09/2010 Patient Sequence Number: 1