MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS HEALON; OVDS

Model Number HEALON 0.85

Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

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.(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during surgery, pushing the plunger of the viscoelastic healon felt different than usual.Reportedly, a fibrous material was injected into the patient's eye from the healon vial.The foreign material was aspirated during the irrigation/aspiration (i/a) procedure and no treatment was required.No issue to the patient was reported.No further information was provided.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 08/10/2017.Device returned to manufacturer? yes.Device evaluation: the complaint sample was returned at the manufacturing site for evaluation.The return product consisted of the glass cylinder (not currently activated), the cylinder holder and the plunger rod which was screwed into the backside of the blue rubber plunger.Visual inspection reveal that the syringe components and the remaining healon solution were clear and free from foreign materials.The customer's reported complaint could not be verified.A video of the procedure was provided and it was evaluated.The video showed a colorless, solid fiber (of approximately 0.7 mm in length) being expelled from the cannula.Identification of the fiber from the video was not possible.It is not known if the origin of the fiber is from the healon syringe or from the cannula or any other component.Because the customer¿s reported complaint was not confirmed by the returned sample, then it was not possible to determine if a product non-conformance occurred and therefore no probable cause could be determined.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.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints on this lot have been received.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 and the reported issue could not be verified.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: 6799713
• MDR Text Key: 83038779
• Report Number: 3004750704-2017-00083
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 04987617160517
• UDI-Public: (01)04987617160517(17)200331(10)UC31357
• Combination Product (y/n): N
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: HEALON 0.85
• Device Catalogue Number: 10294751
• Device Lot Number: UC31357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• 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