MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS HEALON; OVDS

Model Number HEALON GV

Device Problem Material Opacification (1426)

Patient Problem Corneal Edema (1791)

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

Implant and explant dates: if implanted or explanted, give date: not applicable as it is not an implantable device.Initial reporter phone number: (b)(6).All pertinent information available to the manufacturer has been submitted.

Event Description

It was reported that during surgery the physician had issues with a healon gv.During the capsulorhexis, the physician was unable to see anything after using the healon gv, totally opaque.He had to blindly perform surgery due to poor visualization.He had to dislodge the cataract in order to finish.The viscoelastic became opaque when it was put into the eye and the doctor did not observe it before inserting the healon gv into the eye.The physician had to perform the surgery more to the anterior chamber and as a result the patient suffered corneal edema.The procedure went well and no injury was reported.Through follow-up additional information was received.It was learned that the physician suspects that the issue could be with the fridge.Some units could be excessively cold if they are close to the freezer and due to that, it may damage the endothelium.Material not available for investigation as it has been discarded.No further information was provided.

Manufacturer Narrative

Device evaluation: the device was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Retained product evaluation: visual inspection on retained products of the same lot number was performed.No visible defects were found on 47 samples out of 48.One sample contained a glass particle in the solution against the plunger, however it was assessed not being the cause of the customer's reported complaint.An extended investigation has been opened.Corrective action will be implemented based on the investigation results.The solution was clear and colorless in all the samples.All components were included in the product, without defects.Functional test was performed without a malfunction.Chemical and microbiological tests were performed on the retain samples and the results were within product quality specification.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 a product quality deficiency was found in one of the retained samples.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: HEALON
• Type of Device: OVDS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; rapsgatan; uppsala 751 8 2; SE 751 82
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6577279
• MDR Text Key: 75501046
• Report Number: 3004750704-2017-00023
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 25050474500055
• UDI-Public: (01)25050474500055(17)191231(10)UC31100
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: HEALON GV
• Device Catalogue Number: 10200013
• Device Lot Number: UC31100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other