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

Model Number	AAB00
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
Date of event: unknown explant date: if explanted, give date: not applicable, as the lens remains implanted.Initial reporter phone number: (b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that after implantation of aab00 intraocular lens (iol), the patient experienced a -2 diopter difference postop.Through follow up it was learned the physician observed that at the superior position, one of the lens haptics seemed not to be in the capsular bag as planned.It was also noted the haptic could be in the sulcus position.This issue could have potentially caused the myopic refractive surprise.With this it has less possibility of having a mislabeling problem.The physician plans to explant the lens.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no additional investigation request received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Additional Manufacturer Narrative
Additional information: the date of explant was provided in a follow up action, if explanted has been updated.If explanted, give date: (b)(6) 2017.Device available for evaluation: yes.Returned to manufacturer on 4/21/2017.(b)(4).Device visual evaluation: the intraocular lens (iol) was returned to the manufacturer.Visual inspection at 10x microscope magnification was performed.The complaint lens returned cut in three pieces.The condition observed in the lens is consistent with a lens that has been cut due to iol removal process or explant.Due to the condition observed on the lens, the reported complaint could not be verified.All pertinent information available to the manufacturer has been submitted.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6344338
• Report Number: 2648035-2017-00333
• Device Sequence Number: 18995260
• Product Code: HQL
• UDI-Device Identifier: 05050474548732
• UDI-Public: (01)05050474548732(17)200809
• Combination Product (Y/N): N
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2017

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: 08/09/2020
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 03/24/2017; 05/09/2017
• 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: Other