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

Model Number	VT585
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown, not provided.Device manufacture date: unknown, not provided.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a piece of fiber was noticed while injecting viscoelastic healon into the patient's eye.Reportedly, the fiber was removed from the eye.No further information was provided.
Additional Manufacturer Narrative
A piece of foam dressing sealed in a plastic sample jar was returned for evaluation.No product unit and no other unit packaging was returned.Visual evaluation could not confirm the presence of the fiber as reported by the customer.The source of the fiber cannot be determined based on the return.A review of the records was performed.There were no procedural nonconformities or interventions in the manufacturing of the lot that would indicate an elevated potential for particulates in the product solution.There were no similar particulate complaints for the lot number at the time of this review.Review of components used to manufacture the lot show no complaint trends for the syringe, stopper, or cannula (b)(4) lots.No manufacturing root cause could be determined.Review of the customer return could not confirm the presence of the reported particulate.The review indicates the lot was manufactured per procedure and meets the product specifications.Based on the results of the investigation, no quality product deficiency was identified.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information was received and it was learnt that there was no patient injury.Also the manufacturing and expiration dates were received.Therefore added: expiration date: 10/31/2018.Device manufacture date 11/21/2016.(b)(4).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: 6658991
• Report Number: 3004750704-2017-00052
• Device Sequence Number: 1286043
• Product Code: LZP
• UDI-Device Identifier: 05050474547063
• UDI-Public: (01)05050474547063(17)181031(10)026479
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2017

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: 10/31/2018
• Device Model Number: VT585
• Device Catalogue Number: VT585U
• Device Lot Number: 026479
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 07/10/2017; 08/01/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 08/02/2017; 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1