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	Inflammation (1932)
Date of Event	09/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable.If explanted, give date: not applicable.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A zct150 intraocular lens (iol) was explanted from the left eye and replaced with a zct150 225 diopter iol.After the lens exchange, the physician reported that a patient had inflammatory reaction one day post-op; allegedly due to healon5.The physician was able to calm the inflammation by using topical steroids (prednisolone/terazol).There were 20 other surgeries that day and this was the only patient that used healon5 on (b)(6) 2016 and had inflammation issues.No other patients had an inflammatory reaction.This patient has lens implanted in the right eye as well but there was no problem with the right eye.The patient is not allergic to anything and is healthy.Patient's condition improved dramatically with steroid eye drops used topically.Patient is still on steroid and on a tapering schedule at this time until taper is ended.On (b)(6) 2016 the physician determined that the patient showed signs of improvement.Patient's visual acuity is 20/25 +2.This report will capture the healon that was used on (b)(6) 2016.The zct150 lens explanted on this day will be captured on a separate mdr.
Additional Manufacturer Narrative
Additional information was provided in follow up.The iol remains implanted in the right eye and the patient is well now.Device evaluation the complaint device was not returned to the manufacturer.Retained product testing was performed chemical tests ¿ ph, osmolality and visual inspection, microbiological test - bacterial endotoxins.The results were within product quality specification.The solution was clear and colorless all components were included in the product, cannula without defects and no visible defects on the product box.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no previous complaints were received for this order number to date.The directions for use (dfu) was reviewed.No labeling changes are required.Based on the investigation results there is no indication of product 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: 6064264
• Report Number: 3004750704-2016-00028
• Device Sequence Number: 10782602
• Product Code: LZP
• UDI-Device Identifier: 00385445083215
• UDI-Public: (01)00385445083215(17)180131(10)UB31840
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2016

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: 01/31/2018
• Device Model Number: HEALON 5
• Device Catalogue Number: 10290051
• Device Lot Number: UB31840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2016
• Supplement Report FDA Received Date: 11/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZCT150U225 IOL-SN (B)(4) (REPLACEMENT LENS)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR