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)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: unknown if the lens was implanted.If explanted, give date: unknown if the lens was implanted and unknown if explanted.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site inside the lens case but it was not correctly positioned.Visual inspection at 10x microscope magnification showed loose particles and viscoelastic residue on the lens surface.The haptics were observed distorted.The customer's reported complaint was verified.However, it was not possible to determine if the distortion of the haptics was related to how the lens was positioned within the case.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.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 was verified.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) had an haptic bent.No further information was provided.
Additional Manufacturer Narrative
The customer confirmed the following requested information: here was no patient contact with the intraocular lens (iol).The doctor used a backup iol.There was no incision enlargement, sutures, or vitrectomy.The patient was fine after the surgery.No issues were observed.Note: based on the additional information reported above, this event is no longer considered 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
• MDR Report Key: 6632637
• Report Number: 2648035-2017-01039
• Device Sequence Number: 1048628
• Product Code: HQL
• UDI-Device Identifier: 05050474514249
• UDI-Public: (01)05050474514249(17)220331
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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): 09/20/2017

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: 03/31/2022
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1