MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS HEALON; OVDS

Model Number HEALON GV

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown, not provided.If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.Phone number: (b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that there was viscoelastic leakage between the vial and the needle.Reportedly, the cannula was disconnected from the syringe during surgical procedure.No patient injury was reported.The same issue was reported for 4 devices with lot number uc31663.Therefore 4 mdrs will be submitted.This report represents the first of the 4 reports.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 02/09/2018.Device returned to manufacturer? yes.Device evaluation: the device was returned at the manufacturing site for evaluation.The complaint sample consisted of the activated cylinder (containing approximately 0.0-0.050 ml of expellable solution), the cylinder holder, the plunger rod, which was attached at the backside of the blue plunger and the cannula which was attached onto the holder.The cannula was bent backwards as there was no protection sheaths included.The assembled syringe was placed into a plastic bag.Visual inspection showed that the cannula needle was blocked (dried healon solution).The cannula was measured and found to be mounted to a depth of 3.56 mm.When fully mounted, the complaint cannula was observed to be mounted to a depth of 4.06 mm in the cannula mount.This indicates that the cannula was not fully mounted onto the holder as received.A cannula which is not fully mounted in the holder will leak solution.When the cannula needle was unblocked and the cannula fully mounted, the healon solution, from a new cylinder, was easily expelled through the complaint cannula/perforation membrane without any leakage being observed.Additionally the cannula did not demount during the functional testing.The complaint syringe functioned as designed.A piece of plastic from the hub was seen to partially cover the needle hole at the bottom of the cannula hub.This would make expelling of the solution more difficult and could lead to leakage if the cannula was not fully mounted.The customer¿s report of leakage was confirmed, however the demounting of the cannula during expelling of the solution was not verified.Retained product evaluation: visual inspection on the retained products was performed.35 samples were investigated.No visible defects were found on the package, cannula or in the solutions.The solution were clear and colorless.All components were included in the products and were without defects.No visible defects on the product boxes.The printing on the carton and labels is correct.Product deficiency was not found on the retain samples.Functional test from retain products lot# uc31663 was performed.The viscoelastic solution was expelled in a controlled and smooth manner.No leakage was seen in the syringes.The product functioned as designed.Product deficiency was not found on retain samples.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON
• Type of Device: OVDS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7181462
• MDR Text Key: 96943600
• Report Number: 3004750704-2018-00010
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 15050474508221
• UDI-Public: (01)15050474508221(17)200731(10)UC31663
• Combination Product (y/n): N
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2020
• Device Model Number: HEALON GV
• Device Catalogue Number: 10200014
• Device Lot Number: UC31663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Date Manufacturer Received: 02/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1