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	Visual Disturbances (2140)
Date of Event	01/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: na (not applicable) to date, the intraocular lens remains implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported by a patient that she experienced refractive difficulties with her intraocular lenses.The patient had cataract surgery on the left eye on (b)(6) 2016, and cataract surgery on her right eye on (b)(6) 2016.Beforehand, the patient stated she was short-sighted in the left eye and long-sighted (or far-sighted) in the right eye.After surgery, she had visual difficulties and cannot see well either near or far and cannot get glasses due to the diopters.The patient wanted to know what kind of lenses she has; are they aspheric lenses and why were different diopters implanted.The lenses remain implanted.No further information was provided.The patient reports two lenses and related symptoms.An mdr will be filed for each eye.This report represents the lens implanted in the patient's left eye.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens was not returned; therefore an investigation could not be performed.The customer's reported event could not be verified.Manufacturing record review: a review of the manufacturing records was performed.The manufacturing process was evaluated and the lenses were manufactured within specifications.There were no non-conformances related to the reported event.The units were released according to specification in compliance with the product intended use as required.A search on complaints revealed no additional complaints for this order number have been received.Labeling evaluation: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the lenses.Based on the results of the investigation, no product deficiency was identified.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: 6295410
• Report Number: 2648035-2017-00204
• Device Sequence Number: 13707343
• Product Code: HQL
• UDI-Device Identifier: 05050474548701
• UDI-Public: (01)05050474548701(17)190813
• Combination Product (Y/N): N
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2017

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: 08/13/2019
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 02/28/2017
• 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