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	10/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 on (b)(6) 2016, during the 6-hour postoperative visit, the intraocular pressure (iop) was 43 mmhg.The doctor performed an ac tap (anterior chamber).The left eye (os) was treated with an iop reducing medication.The patient was seen on (b)(6) 2016, and the intraocular pressure os was 12 mmhg.The event was considered resolved without sequelae.The patient recovered.No further information was provided.
Additional Manufacturer Narrative
Device evaluation the device was not returned to the manufacturer.Therefore, product testing was not possible.Visual inspection on retained products was performed on parallel batch lot# ub32008.48 samples were investigated.No visible defects were found on the package, cannula or in the solutions.The solution was 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 product.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: 6695328
• Report Number: 3004750704-2017-00063
• Device Sequence Number: 11009257
• Product Code: LZP
• UDI-Device Identifier: 00385445083215
• UDI-Public: (01)00385445083215(17)180228(10)UB32009
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 03/31/2018
• 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: 80 YR