MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065751763

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Swelling (2091); Zonular Dehiscence (2698)

Event Date 06/29/2018

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.(b)(4).

Event Description

A customer reported that during a laser assisted cataract procedure, a micro adhesion was noted on the capsule nasally.The doctor used blue dye to visualize the capsule prior to management.The micro adhesion was released without consequence to the patient, and the capsulorhexis was seen round and complete.During phacoemulsification, and after lens spin, zonular dehiscence was observed in the superior half of the capsule bag.Approximately 180 degrees of the capsule was seen detached.The doctor increased the size of the primary incision, and used a lens loop to extract the cataract from the eye.An anterior vitrectomy was completed, and an alternate intraocular lens implant was inserted into the anterior chamber.Four sutures were used to close the primary incision.The surgeon examined the patient the following day and reported she is doing better than expected.The cornea was swollen, but the hemorrhage in the anterior chamber had improved.The patient was reported to have a dense cataract.The patient is scheduled to follow up for a retinal consult.

Manufacturer Narrative

This is a (b)(6) year-old female patient was scheduled for laser assisted cataract extraction and intraocular lens implant (iol) in the left eye (os).The customer reported ¿a micro-adhesion was seen on the capsule nasally¿ this investigation will represent the console portion of the case.The clinical application specialist (cas) provided feedback on the case.The following is a review of the information: ¿trypan blue was used to visualize the capsule prior phacoemulsification.The micro-adhesion was released without consequence to the patient.The capsulorhexis was seen to be round and complete.During phaco procedure (after a successful lens spin), zonular dehiscence was observed in the superior half of the capsular bag.The surgeon attributes this anatomical anomaly to the reported event of pc tear and resulting in the anterior vitrectomy.A hemorrhage was noted to have been present in the anterior chamber, as well as corneal swelling.The patient was sent to a retinal specialist as a follow up precaution.There were approximately 180 degrees of the capsular bag seems to have be detached.As such, the surgeon increased the size of the primary incision.A lens loop was used to extract the cataract from the eye.An anterior vitrectomy was then performed and completed.A 19.5(d)-diopter intraocular lens (iol) was implanted in the anterior chamber (ac).The surgeon originally planned for a 23.5d.There were four sutures used to close the primary incision.The surgeon also mentioned that on the first day of the patients¿ post-operative visit ¿the patient is doing better than expected.¿ the clinical application specialist (cas) provided images and a list of parameters along with a report overview of the event.The cas has confirmed that the information images and parameters were all listed to have been 'within normal limits'.It was also mentioned by the cas that 'the controls points were appropriate and well placed.' in conventional cataract surgery, without laser assistance, the incidence of anterior capsular tears has been documented from 0.79% in very experienced hands to 5.3% within teaching institutions.The importance of an intact capsulorhexis for safe phacoemulsification is well recognized.In fact, irregular edges are known to promote radial tearing.Prior to the innovation of the continuous curvilinear capsulorhexis, it was widely known that extensions of tears most often occur in v-shaped notches (or peaks as noted in the report description) of the anterior capsule rim.The determinant of the direction of tearing is the sum of the vector forces of the surgeon¿s hand during the capsulorhexis and the tension applied by the zonular fibers.A variety of intraoperative factors may lead to corneal edema following intraocular surgery.Patients who have preexisting endothelial pathological conditions (not limited to but including; fuch¿s corneal dystrophy, prior eye surgery, etc.) may be more likely to present with corneal edema.Acute corneal edema following cataract surgery usually fully resolves in the setting of a normally functioning endothelium, aided by an appropriate post-operative regimen.However, in some cases, corneal endothelial cells are damaged irreversibly, resulting in aphakic or pseudophakic bullous keratopathy.Corneal edema, from inadequate endothelial pump function, is one of the most common complications of cataract surgery.The possible contributions to a post-operative edematous cornea may include lack of sufficient ophthalmic viscoelastic device (ovd) used to protect the endothelium, excessive prolonged use of ultrasonic energy delivered by the phaco handpiece, inappropriate infusion sleeve orientation directing irrigation fluid directly against the corneal dome, aggressive iol insertion, instrument contact, or retained lens fragments.It should be noted however that phacoemulsification has the lowest rates for corneal edema and corneal transplantation (0.62%) when compared to other cataract surgeries (icce=1.4%, ecce=0.63%) 1.In most instances, minimal endothelial cell loss in cataract surgery has a widely accepted risk to benefit ratio.Advances in endocapsular phacoemulsification procedures, instruments, iols, and related materials such as viscoelastic substances appear to have helped decrease the degree of endothelial damage.Several factors interact to ensure corneal transparency in the normal eye.The corneal stroma naturally imbibes water because of two forces: the hydrophilic proteoglycans that exert an osmotic pressure to pull water into the stroma and the intraocular pressure that drives water through the endothelial barrier.The corneal endothelium counteracts this response actively by dehydrating the stroma by acting as a pump, as well as passively through the integrity of the cellular membrane barrier.The epithelial cellular membrane also acts as a barrier.The endothelial barrier is leaky, but the leak rate normally equals the metabolic pump rate so that the endothelium maintains stromal water content to 78%.Corneal edema post-operatively is often times transient and resolves itself over time provided there is enough functional endothelium left.Other postoperative factors include elevated intraocular pressure (iop) or inflammation which should be separately addressed if persistent.The main reason for persistent corneal edema is inadequate endothelial pump function keeping the corneal stroma in its relatively dehydrated and clear state.It is believed that at least 600 cells/mm2 are needed to provide adequate corneal dehydration, and clarity.Corneal edema after cataract surgery can be caused by various factors as mentioned above.There is insufficient information regarding the patient¿s ocular history and detailed events surrounding the occurrence.Ultrasonic power is a setting controlled and modified by the surgeon, therefore contributor to the event may be surgical technique as well as patient corneal pathology.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The system was manufactured on may 6, 2015.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7711783
• MDR Text Key: 114761997
• Report Number: 2028159-2018-01540
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/23/2018
• Supplement Dates Manufacturer Received: 10/01/2018
• Supplement Dates FDA Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IOL; LENSX; IOL; LENSX
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR