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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER OCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER OCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 8065741076
Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The customer reported intraocular lens implant (iol) was incorrect calculated, which caused the wrong lens to be implanted. This is the 2nd of 4 patients affected. Additional, related information was requested but was not obtained. The measurement of axial length measurement has the greatest potential for error in calculating iol power. Traditionally, contact a-scan ultrasonography is used. This measures the time taken for sound to traverse the eye and converts it to a linear value using a velocity formula. Part of the ultrasound beam reflects back from each surface in the eye ¿ cornea, anterior lens, posterior lens, and retina. The reflected beam is translated into an image showing lines (spikes) for each surface. The distance between the corneal and retinal spikes gives the axial length of the eye. The alignment of the a-scan is vitally important. If the alignment is incorrect, the length of the eye will be underestimated. Most systems rely on the patient fixing on a target ¿ usually a light in the probe. Patients with poor vision, whether from cataract or from some other pathology, are less likely to fixate accurately, and are more prone to biometry errors. Tips for accurate measurement of axial length (using applanation): ensure the machine is calibrated and set for the correct velocity setting (e. G. Cataract, aphakia, pseudophakia); the echoes from cornea, anterior lens, posterior lens, and retina should be present and of good amplitude; misalignment along the optic nerve is recognized by an absent scleral spike; the gain should be set at the lowest level at which a good reading is obtained; take care with axial alignment, especially with a hand-held probe and a moving patient (as described above); don't push too hard ¿ corneal compression commonly causes errors; errors may arise from an insufficient or greasy corneal meniscus due to ointment or methylcellulose used previously. Extremely dense cataracts create difficulties, as they absorb sound as it passes through the lens. A higher gain setting may be necessary to achieve adequate spikes. Posterior staphylomata in myopic eyes not only cause an elongated globe, but often tilt the macula as well so that the ultrasound beam is deflected. There are known reasons for biometry errors include: people in a hurry, lack of training or accessible guidelines, reliance on others, technical failure (rarely), and human error (often). Some common mistakes that may result in unexpected refractive outcome include: wrong a-constant selected, wrong formula used, wrong k-readings entered by hand (90 degrees out), biometry print-out stuck in wrong patient's notes, wrong patient in theatre, reversed iol optic, or wrong iol implanted. The operators manual includes the warning: ensure that the correct technique (contact or immersion) is selected for the technique being performed. Incorrect technique selection will impact the accuracy of the results. Contact - in the contact technique, readings are obtained by placing the biometry probe directly on the patient¿s cornea. Immersion - in the immersion technique, an immersion shell containing the probe is placed on the patient's eye and filled with solution between the probe and the cornea. Since the probe is not touching the cornea, there is an offset on the display between the peak from the probe tip and the peak from the cornea. The system and probe were both examined. During the examination, it was determined that the probe-shell used for immersion measurements (which is not a product manufactured by our company) was found cracked. The company representative asked for a replacement and to be installed by the customer. The cracked probe was considered to have attributed to the reported event. The system and probe however, were tested and found to meet product specifications. The system was manufactured on november 13, 2007. Based on qa assessment, the product met specifications at the time of release. The cracked probe-shell (non-manufacturer product) is attributed to the reported event. The probe and system were found to function to specifications. Therefore, they are not suspected to have contributed to the reported event. The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
 
Event Description
A nurse reported that the diagnostic equipment provided incorrect intraocular lens (iol) calculations on a female patient. The wrong power iol was implanted. The patient will require an additional procedure to exchange the incorrect iol. Additional information is not expected. This is one of four related reports being filed for this facility.
 
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Brand NameOCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer (Section G)
ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer Contact
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6727427
MDR Text Key149109118
Report Number2028159-2017-03120
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K844686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8065741076
Other Device ID NumberV.1.15
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2007
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: 07/20/2017 Patient Sequence Number: 1
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