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

Model Number	AR40M
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.If explanted, give date: not applicable as the lens remains implanted.Device evaluation: the device was not returned to the manufacturer for evaluation as the lens remains implanted.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 that no additional investigations have been requested 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.
Event or Problem Description
It was reported that a failed cataract surgery left a patient with extreme double vision.Through follow up, it was learned that initially, a zmb00 17.5 diopter intraocular lens was implanted on (b)(6) 2014, in the patient's right eye.After the implant, the patient experienced double vision.On (b)(6) 2014, the physician piggy-backed an ar40m 1.0 intraocular lens.This was no help as the patient continued to experience double vision.The physician will be fitting the patient with an extended wear (30 day) contact lens to see if that resolves the double vision.There have been no other secondary medical or surgical procedures.No injuries or issues other than the double vision.The lenses are still implanted and there are no plans to explant at this time.No further information was provided.This report will capture the ar40m lens implanted on (b)(6) 2014.A separate mdr will be filed for the zmb00 iol.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6539312
• Report Number: 2648035-2017-00783
• Device Sequence Number: 1659178
• Product Code: HQL
• UDI-Device Identifier: 05050474501812
• UDI-Public: (01)05050474501812(17)181204
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/02/2017

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: 12/04/2018
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/02/2017
• 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