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

Model Number	AR40M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no indication at the time of this report that the lens has been explanted.(b)(6).Device evaluation: complaint device was not returned for evaluation.The reported issue could not be confirmed.  the manufacturing production order (po) was evaluated and the devices were manufactured within specifications.The units were released according to specification.During manufacturing process, all lenses are cleaned and inspected under 10x microscope magnification and defective devices are rejected.  a review of the complaints related to the production order was performed and the results revealed no other complaints for this order number.A historical complaint data review was performed and results did not identify any product deficiency.  the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.  based on the investigation results, there is no indication of a product malfunction or product quality deficiency.  all pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during implantation of an ar40m intraocular lens (iol), haptic broke.No further information was provided.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5940834
• Report Number: 2648035-2016-01429
• Device Sequence Number: 19234171
• Product Code: HQL
• UDI-Device Identifier: 05050474501829
• UDI-Public: (01)05050474501829(17)201112
• Combination Product (Y/N): N
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2016

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: 11/12/2020
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2016
• Initial Report FDA Received Date: 09/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1