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	10/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant and explant dates: if implanted or 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 one day post-op ((b)(6) 2016), the intraocular pressure (iop) in the right eye (od - oculus dexter) of the (b)(6) year-old male patient, was 35 mmhg (millimeter of mercury).Reportedly, the od was treated with an iop reducing medication and the patient was instructed to continue the medication (one drop twice a day).The patient was seen again by the doctor on (b)(6) 2016, and the iop was 15 mmhg.The adverse event was considered resolved and the iop medication was discontinued.The suspect product was discarded by the customer.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in the initial mdr, the lot number ub32009 was incorrectly entered into the serial number.Device evaluation: the complaint sample was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Retained product evaluation: visual inspection on retained products was performed on parallel batch lot# ub32008.The 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.No visible defects on the product boxes.The printing on the carton and labels is correct.Chemical and microbiological tests were performed on the retain samples and the results were within product quality specification.Product deficiency was not found on the retain samples.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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 abbott medical optics has been submitted.

• Brand Name: HEALON
• Common Device Name: OVDS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6688781
• Report Number: 3004750704-2017-00054
• Device Sequence Number: 1971481
• 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: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

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: 07/11/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 08/03/2017
• 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: 78 YR