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	No Code Available (3191)
Date of Event	10/20/2016
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.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the surgery site had a case of mild toxic anterior segment syndrome (tass) in the left (os) of the patient.On (b)(6) 2016, during the 1-day postoperative visit for the second eye (os), the anterior findings had worsened compared to the 6-hour post-operative study visit.The doctor determined that the anterior findings along with the subjective complaints were severe enough to require medical intervention and the steroid dosing was increased from what the study protocol specified.Conservatively, the adverse event was categorized as mild anterior segment syndrome (tass).The event was resolved on (b)(6) 2016 without sequelae.The cause of the tass is thought to be related to an issue with the sterilization of the surgical instruments.The doctor reports two events of tass on the same day.A separate report is being submitted for each case.No further information was provided.
Additional Manufacturer Narrative
Device evaluation the device was not returned to the manufacturer for evaluation.Device inspection could not be performed; however, re-tests were performed on retain samples.Visual inspection on retained products was verified and no product deficiency was not found on retain samples.Manufacturing records were reviewed and the product was manufactured according to specification.Sterilization was processed and no deviations were found that affects the sterility of the device.All results were within 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: 6697997
• Report Number: 3004750704-2017-00073
• Device Sequence Number: 11196446
• Product Code: LZP
• UDI-Device Identifier: 00385445083215
• UDI-Public: (01)00385445083215(17)180228(10)UB32009
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/22/2017

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: 10/26/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 11/22/2017
• 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: 76 YR