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

Model Number	VT585U
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as the product is not implantable.If explanted, give date: not applicable, as the product is not implantable.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported the doctor noticed a ''bubble'' material that repelled the phaco immediately after injecting healon endocoat model vt585u.Also, the doctor saw shadowing, debris, and 2 air bubbles coming out of the healon.Reportedly, the doctor attempted to aspirate without any success.The doctor also felt that this event weakened the posterior capsule, so a sulcus lens was implanted instead.The material almost completely covered the pupillary field, but once the lens was implanted, it moved behind the iris.At the patient's one week post-operative visit with the doctor on (b)(6) 2017, the 2 air bubbles were no longer visible and the patient was prescribed combigan eye drops as a prophylactic measure.Reportedly, there was no patient injury and the patient is doing okay post-operatively.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on unknown.Device returned to manufacturer? yes.The customer returned one opened, syringe unit of lot 026776.The contents of the syringe was fully expressed.Visual evaluation of this unit could not identify a defect.Evaluation of returned units could not confirm the complaint indication.The batch review indicates the lot was manufactured per procedure and meets the product specifications.No complaint trends have been identified for this complaint indication.As a result of the investigation, there is no indication of a product quality deficiency.No assignable manufacturing root cause could be determined.No further actions are recommended at this time.No trends have been indicated related to this complaint indication for the healon endocoat product line.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON ENDOCOAT
• Common Device Name: OVDS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7204551
• Report Number: 3004750704-2018-00015
• Device Sequence Number: 11056149
• Product Code: KYB
• UDI-Device Identifier: 05050474547063
• UDI-Public: (01)05050474547063(17)190531(10)026776
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• 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): 06/12/2018

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 Expiration Date: 05/31/2019
• Device Model Number: VT585U
• Device Catalogue Number: VT585U
• Device Lot Number: 026776
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 06/12/2018
• 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: 73 YR