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

Model Number	AR40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported a sensar intraocular lens (iol), model ar40e 26.5 diopter, was explanted from a female patient's left eye on (b)(6) 2017 due to poor post-operative refraction.No additional information provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 08/28/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection under the microscope showed that the lens was cut from the edge across the optic.The condition observed in the lens and the way the cut was formed was consistent with a lens that was cut due to iol removal or explant process.Due to the condition of the lens additional analysis was not possible.The customer's reported complaint could not be 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) 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.
Additional Manufacturer Narrative
Additional info: additional information was received and it was learnt that there no other visual issues.The intraocular lens (model ar40e, +26.5 dioptre) was explanted and replaced with another lens, same model smaller diopter (+21.5).No complications were reported during the explant.The patient was reported doing fine when discharged.Also the surgeon name was provided.No further information was provided.(b)(6).Health professional: yes, occupation: physician.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 92705
• MDR Report Key: 6793613
• Report Number: 2648035-2017-01496
• Device Sequence Number: 10983124
• Product Code: HQL
• UDI-Device Identifier: 05050474514164
• UDI-Public: (01)05050474514164(17)201222
• 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 Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2017

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: 12/22/2020
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 08/29/2017; 09/19/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 09/21/2017; 10/13/2017
• 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