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 Code Available (3191)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Expiration date: unknown, not provided.If implanted, give date: not applicable, as the product is not implantable.If explanted, give date: not applicable, as the product is not implantable.Device manufacture date: unknown, not provided.Incision enlargement.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a shadowy/blob was noticed into the patient's eye while injecting the viscoelastic endocoat.Reportedly, it could not be aspirated out with the i/a (irrigation/aspiration) or the phaco handpiece.It would repel whatever touched it and it was very sticky.They ended up leaving it in the eye and it dissolved after a few days.It was also reported that the patient received epinephrine.Additional information was received and it was learnt that the incision was enlarged.A capsular tension ring was implanted together with a symfony zxr00 +22.0 diopter.To date the lens remains implanted.No vitrectomy was performed.No further information was provided.
Additional 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.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 there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to (b)(4), inc.Has been submitted.

• Brand Name: HEALON ENDOCOAT
• Common Device Name: OVDS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7284776
• Report Number: 3004750704-2018-00020
• Device Sequence Number: 18872928
• Product Code: LZP
• UDI-Device Identifier: 05050474547063
• UDI-Public: (01)05050474547063(17)190630(10)026930
• Combination Product (Y/N): Y
• 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): 07/26/2018
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: VT585U
• Device Catalogue Number: VT585U
• Device Lot Number: 026930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005