MAUDE Adverse Event Report: BAUSCH + LOMB AMVISC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Model Number 59081L

Device Problems Detachment of Device or Device Component (2907); Device Handling Problem (3265)

Patient Problems Hemorrhage/Bleeding (1888); Vitreous Loss (2142); Vitreous Hemorrhage (2143); Capsular Bag Tear (2639)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that while the surgeon was injecting viscoelastic into the patient¿s eye, the cannula came off and penetrated the posterior chamber.Reportedly, the scrub nurse pulled the rubber stopper from the end of the syringe (instead of twisting as described in the dfu) and inadvertently pulled the luer-lock off.Cannula was attached and the syringe was then passed to the surgeon, who tightened the cannula and held the hub during injection of the amvisc viscoelastics, but did not realize the luer-lock was not on the syringe.Some amvisc viscoelastics was expelled outside the eye to repress bubbles/air, but the cannula did not detach.The cannula; however, detached under pressure during injection into the anterior chamber.Initially, no significant ocular injury was noticed.Continuous curvilinear capsulorhexis was completed, but rotation of the implanted lens was not possible in the bag after first groove, even after repeated hydrodissection was performed.The lens was grooved and cracked without rotation and partially removed and elevated with amvisc viscoelastics.After removal of most of the lens, it was clear there was a large posterior capsule rent and vitreous fluid in the anterior chamber.As a precaution, pars plana vitrectomy (ppv) ports were placed and when infusion turned on, it was evident that vitreous hemorrhage was present and began to circulate in the anterior chamber and vitreous.At this point, possible retinal injury was suspected.The lens and vitreous fluid were removed from the anterior segment and binocular indirect ophthalmic microscope (biom) was placed with intention to inspect retina and treat any retinal break, but no fundal view was possible.The patient was in significant pain and the procedure was abandoned.Additional information has been requested, but has not be been received.

Manufacturer Narrative

Based upon the complaint trend review, the volume of complaints is within the acceptable control limits and no complaint trend is observed.The product is being enhanced with a retention clip to mitigate the possibility of user error as occurred in this event.

Manufacturer Narrative

Additional information: the lens was not available for evaluation; therefore, a product evaluation could not be performed.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.Based on the available information, the event is likely attributed to failure in following the directions for use (dfu) for the device.

Event Description

Reportedly, the surgery was terminated as the patient had an intraoperative choroidal hemorrhage, which according to the surgeon, the best management for treating was to increase the intraocular pressure that would potentially limit the bleeding.The surgeon therefore terminated the surgery so the eye would be a closed system.The patient had several follow-up visits since surgery and has had laser treatment (cyclodiode) to control elevated intraocular pressure.A b-scan ultrasound has confirmed the presence of choroidal hemorrhage.No further intervention is planned at the moment.The patient has guarded prognosis for achieving good vision.

• Brand Name: AMVISC VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 7853779
• MDR Text Key: 119488151
• Report Number: 0001313525-2018-00160
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): Y
• PMA/PMN Number: P810025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 59081L
• Device Catalogue Number: 59081L
• Device Lot Number: 026946
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR