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

Model Number	AAB00
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.The exact date of when the reported refractive error was observed was not provided (2017).(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (model aab00, +19.5 diopter) was explanted in a secondary surgical procedure from the right eye of a male patient because of a post-operative refractive error.Reportedly another lens, same model higher diopter (+21.0) was implanted as a replacement.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 09/25/2017.Device returned to manufacturer? yes.The intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed that the lens was cut in pieces, probably to make the removal possible.However, only one part of the lens was returned.Considering the condition of the lens, additional analysis was not possible.The customer's reported complaint could not be verified.The manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.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.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6889445
• Report Number: 3011852734-2017-00018
• Device Sequence Number: 633633
• Product Code: HQL
• UDI-Device Identifier: 05050474548657
• UDI-Public: (01)05050474548657(17)201220
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 12/20/2020
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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