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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Vitrectomy (2643); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: unknown if the was implanted.If explanted, give date: unknown if the was implanted and therefore unknown if explanted.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during the implantation of an intraocular lens (iol), one haptic broke inside the patient's eye.No further information was provided.
Additional Manufacturer Narrative
Additional information was received and it was learnt that the incision was enlarged to remove the intraocular lens and an anterior vitrectomy was performed.Another lens was implanted during the same surgical procedure, same model higher diopter as the account did not have the same diopter in stock.Reportedly, during the last refraction, the patient was observed being myopic of -1.00 -1.50 60 20/50.No further information was provided.Date of birth: (b)(6).Sex/gender: male.Updated from product problem to adverse event and product problem.Outcomes attributed to adverse event: required intervention.Type of reportable event, from malfunction to serious injury.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: 6809407
• Report Number: 2648035-2017-01525
• Device Sequence Number: 992845
• Product Code: HQL
• UDI-Device Identifier: 05050474502024
• UDI-Public: (01)05050474502024(17)210712
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2018

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: 07/12/2021
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 08/25/2017; 01/11/2018
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 09/19/2017; 02/07/2018
• 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