MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS HEALON ENDOCOAT; OVDS

Model Number	VT585U
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant dates: if implanted or explanted, give date: not applicable as this is not an implantable device all pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a black thread was found in the patient's eye coming from the viscoelastic healon endocoat.No further information was provided.
Additional Manufacturer Narrative
In the initial mdr the incorrect manufacturing date was entered; therefore updated device manufacture date: 06/06/2016.Additional info: device available for evaluation? yes.Returned to manufacturer on: 02/01/2017.Device returned to manufacturer? yes.Device evaluation: the complaint sample was returned to the manufacturer for evaluation.Visual inspection showed that the cannula was attached to the syringe and only a small amount of product remained within the syringe.A photo was provided showing a fiber in the eye.The fiber was not returned for evaluation.The source of the fiber could not be determined.The customer's reported event could not be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.As a result of the investigation, no manufacturing root cause could be determined.No product deficiency was identified in the investigation.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: HEALON ENDOCOAT
• Common Device Name: OVDS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6239598
• Report Number: 3004750704-2017-00001
• Device Sequence Number: 13547674
• Product Code: LZP
• UDI-Device Identifier: 05050474573574
• UDI-Public: (01)05050474573574(17)180531(10)026283
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: VT585U
• Device Catalogue Number: VT585U
• Device Lot Number: 026283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1