MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS HEALON; OVDS

Model Number	HEALON 0.85
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Intraocular Pressure Increased (1937); Vitrectomy (2643)
Date of Event	03/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is not an implantable device.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a patient experienced endophthalmitis post procedure.Healon gv was the viscoelastic used.The date of surgery was (b)(6) 2017.At day two (2) post procedure the patient was seen in the physician¿s office and was 20/20.On friday(b)(6) 2017 the patient called the physician and reported a severe infection.The eye was inflamed, oozing puss, swollen, and had a pressure of 40.The physician sent the patient to a retina specialist and a vitrectomy was performed.The patient was given antibiotic injections.The patient had a retinal hemorrhage.The reporting physician noted that during the procedure the tech folded the intraocular lens (iol) with her gloved fingers.The iol used was a non amo lens.The healon gv product will not be returned as it has already been discarded.Follow up was conducted to obtain the current status of the patient however per the center contact it is unknown.The only additional information the contact provided was the gender and age of the patient and that he was treated with iv antibiotics.
Additional Manufacturer Narrative
Catalog number in the initial report was populated with healon 0.85.However the correct catalog number is 10294801.Device evaluation the device was not returned to the manufacturer for evaluation.The reported issue was not confirmed.Retain samples underwent chemistry, microbiological and visual evaluation.Results were within specifications.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no complaints have been reported on this batch previously.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: 6510169
• Report Number: 3004750704-2017-00015
• Device Sequence Number: 13740474
• Product Code: LZP
• UDI-Device Identifier: 00385445085417
• UDI-Public: (01)00385445085417(17)191031(10)UB32621
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/11/2017

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: 10/31/2019
• Device Model Number: HEALON 0.85
• Device Catalogue Number: 10294801
• Device Lot Number: UB32621
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 07/11/2017
• 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: 74 YR