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

Model Number	AR40M
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown, information not provided.If implanted, give date: unknown, it is unknown if the lens was implanted.If explanted, give date: unknown, it is unknown if the lens was implanted and therefore unknown if the lens was explanted.Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site.Only the box, empty lens case and some labels were returned.Therefore, product testing could not be performed and 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 on complaints revealed that no other complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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.
Event or Problem Description
It was reported that a haptic was bent on a sensar monofocal intraocular lens (iol), model ar40m -3.0 diopter.No additional information was provided.
Additional Manufacturer Narrative
Additional information: during a follow up, the customer stated that the issue was a bent haptic due to loading.There was no patient contact and therefore, no patient injury.If implanted, give date: not applicable, the lens was not implanted.If explanted, give date: not applicable, the lens was not implanted; therefore, not explanted.The additional information provided above deems this event as not reportable.(b)(4).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: 6806610
• Report Number: 2648035-2017-01519
• Device Sequence Number: 139330
• Product Code: HQL
• UDI-Device Identifier: 05050474501799
• UDI-Public: (01)05050474501799(17)191107
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/07/2019
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 08/20/2017
• Supplement Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1