MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS SENSAR; MONOFOCAL IOLS

Model Number	AR40E
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Loss of Vision (2139); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact date of the onset of symptoms was not provided.(b)(6).An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (model ar40e, +18.0 diopter) was implanted in the eye of a male patient on (b)(6) 2016.The lens was explanted on (b)(6) 2017 because the surgeon noticed a "putty" on the lens that was causing loss of vision.Another ar40e, with the same diopter size, was inserted into the eye but the surgeon noticed that this lens was foggy, not quite clear, and it had some substance on the anterior of the lens.Reportedly, the lens was removed and replaced during the same surgical procedure with a pcb00 lens.The patient vision was reported being normal.No further information was provided.Two mdrs will be filed for the 2 ar40e lenses.This report is to record the first ar40e lens implanted and subsequently explanted.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 11/07/2017.Device returned to manufacturer? yes.Device evaluation: only half of an intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed loose fibers/particles and material looking like body fluids on the lens, related to the handling of the unit out of a sterile environment.The haptic was observed slightly distorted.The customer's reported complaint for putty on the lens was not verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional investigation requests for this order number have been received.Labeling review: the directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.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: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6978924
• Report Number: 2648035-2017-01945
• Device Sequence Number: 10873660
• Product Code: HQL
• UDI-Device Identifier: 05050474502062
• UDI-Public: (01)05050474502062(17)181009
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/09/2018
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 12/27/2017
• 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