MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS HEALON; OVDS

Model Number	HEALON 5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	06/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: not applicable as this is not an implantable device.If 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 following cataract surgery, the patient returned for the 6-hour postoperative visit.The intraocular pressure (iop) left eye (os) was 36mmhg.The left eye was treated with iop reducing mediation.The patient returned for the 1-day postoperative visit on (b)(6) 2016.The intraocular pressure os was 10mmhg.The adverse event was considered resolved without sequelae and the iop-reducing medication was discontinued.Patient recovered.No further information was provided.
Additional Manufacturer Narrative
Device evaluation the healon was not returned to the manufacturer.Therefore product testing could not be performed on the actual lot used by the customer.Visual inspection on retained products was performed and 48 samples were investigated.No visible defects were found on the package, cannula or in the solutions.The solution were clear and colorless.All components were included in the products and were without defects.Product deficiency was not found on retain samples.The customer's reported event could not be confirmed.Manufacturing records were reviewed and the healon was manufactured according to specification.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: HEALON
• Common Device Name: OVDS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6695250
• Report Number: 3004750704-2017-00059
• Device Sequence Number: 1246386
• Product Code: LZP
• UDI-Device Identifier: 00385445083215
• UDI-Public: (01)00385445083215(17)180228(10)UB32009
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/04/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: HEALON 5
• Device Catalogue Number: 10290051
• Device Lot Number: UB32009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/04/2017
• 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: 63 YR