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 Consequences Or Impact To Patient (2199)
Date of Event	07/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number not provided.Expiration date and complete unique identifier (udi#): unknown as the lot number was not provided.Implant and explant dates: if explanted, give date: not applicable as this is not an implantable device.Device manufacture date(s): unknown, because the lot number was not provided.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during surgery the cannula of the viscoelastic healon endocoat, spit out a few metal fragments into the anterior chamber of the patient's eye.The surgeon was able to remove them via irrigation/aspiration (i&a) procedure.The patient was reported being fine post operatively.No further information was provided.
Additional Manufacturer Narrative
Date of this report: in the initial mdr, an incorrect date (9/6/2016) was entered.The correct date of the report is 09/07/2016.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information: additional information revealed the lot number of the device therefore the following fields were updated: model #/lot #.Lot #: 025883.Expiration date: 07/31/2017.(b)(4).Device manufacture date: 08/06/2015.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 12/12/2016.Device returned to manufacturer? yes.Device evaluation: the device was returned at the manufacturing site for evaluation.Visual inspection of the returned syringe and its contents could not confirm the presence of particulates within the solution.No particulates were returned for evaluation.The needle of the cannula was observed bent.The customer's reported complaint could not be verified.Retain product testing: the retained product was not evaluated as there was no inventory left for this lot.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 additional complaints for this lot number have been received.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 ENDOCOAT
• Common Device Name: OVDS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5934974
• Report Number: 3004750704-2016-00018
• Device Sequence Number: 16275983
• Product Code: LZP
• UDI-Device Identifier: 05050474547063
• UDI-Public: (01)05050474547063(17)150227(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup,Followup
• Report Date (Section B): 01/30/2017

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: 07/31/2017
• Device Model Number: VT585U
• Device Catalogue Number: VT585U
• Device Lot Number: 025883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/15/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 09/07/2016
• Supplement Report FDA Received Date: 09/08/2016; 12/13/2016; 01/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1