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

Model Number	AR40M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable as the lens was not fully inserted.If explanted; give date: not applicable as the lens was not fully inserted.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a haptic broke off from an ar40m intraocular lens (iol) during insertion (in the middle of the procedure); therefore, another iol was inserted.The incision was slightly enlarged.No sutures were required.The lens was cut in half to remove it from the eye.There was not an additional surgical procedure scheduled.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Additional information: the right eye was involved in the event.Replacement lens: was another ar40m +1.5 diopter lens.Device evaluation: only approximately half of the lens and a cartridge were returned.There is no haptic attached to the portion of the lens returned.Visual inspection at 10x microscope magnification was performed.Residues of what appears to be ophthalmic viscoelastics (ovds) were observed on the cartridge.A haptic is adhered to the cartridge loading zone.The reported device problem code of haptic detached was verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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: 6188097
• Report Number: 2648035-2016-02068
• Device Sequence Number: 509408
• Product Code: HQL
• UDI-Device Identifier: 05050474514218
• UDI-Public: (01)05050474514218(17)210720
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 07/20/2021
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 01/24/2017
• 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