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

Catalog Number 8065741076

Device Problems Inadequacy of Device Shape and/or Size (1583); Output below Specifications (3004)

Patient Problem No Information (3190)

Event Date 03/02/2017

Event Type  Injury  

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.

Event Description

A surgeon reported that there was a problem with the biometric length measurement and the incorrect intraocular lens implant (iol) was implanted into the patient.The patient was under corrected.The patient required an additional procedure to remove the incorrect iol and implant a new one.The patient's symptoms have resolved.

Manufacturer Narrative

The completed questionnaire was reviewed by an alcon clinical analyst, who stated the following: on (b)(6) 2017 this event took place.This is the first of two cases reported, where the biometry is alleged to have contributed to the reported event.The patient was under corrected, as an 11.0 diopter (d) iol was inserted into the right eye (od), instead of the correct iol of 24.0d.The surgeon did not detect the issue prior to the intraocular lens implant (iol) insertion, during the surgery.As such, the wrong lens was implanted into the eye.A secondary iol exchange surgery was required, (scheduled on (b)(6) 2017).The surgeon does not indicate the equipment caused the reported event.This is a (b)(6) male patient was diagnosed with anisocoria post-operatively.The procedure was listed as cataract extraction with intraocular lens implant (iol) right eye (od).No previous ocular or medical history was provided.A questionnaire was completed and given the clinical analyst to review.Pre-operative data: the intraocular pressure was listed at 16 mmhg before the case and 15 mmhg after the case.The post-operative refraction was listed as20/50 right eye (od) un-corrected visual acuity (ucva), the refraction is listed as +1.50-1.50x89 (best corrected) bcva: 20/100.The axial length listed was 22.94 od with the iol master.Surgical data: superior-temporal incision was made and viscoat was used as the ophthalmic viscoelastic device (ovd).Post-operative data: ucva: 20/700, bcva 20/400.Auto-refractor used following the implantation of the iol.There was no posterior opacification or 2nd cataract indicated to have been present at the time.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 was examined.There was no problem found in the system and no issue was found in the axial length (al) measurement.The company representative changed the preset from probe check to preset one and confirmed that all parameters were in specifications.Based on qa assessment, the product met specifications at the time of release.There was no problem found in the system.Therefore, the root cause of the reported events cannot be established.(b)(4).

• Brand Name: OCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM
• Type of Device: SYSTEM, 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6471526
• MDR Text Key: 72084811
• Report Number: 2028159-2017-01481
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K844686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065741076
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ULTRASERT DEL SYS (INJECTOR
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 77 YR