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 Codes	Capsular Bag Tear (2639); No Code Available (3191)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was inserted and removed.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that during implantation of an aab00 18.0 diopter intraocular lens (iol), the patient's posterior capsule tore so the physician removed the lens.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 7/19/2017.Device returned to manufacturer ¿ yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.The lens was evaluated using a microscope under 10x magnification.No defects were observed only viscoelastic residues were observed.The customer's reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints for this production order were received.Labeling review: 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.
Additional Manufacturer Narrative
Corrected data: in the initial mdr, outcomes attributed to adverse events required intervention should have been selected versus other.The following section has been updated accordingly: outcomes attributed to adverse event: required intervention.Additional information: additional information received reported that a capsular tear occurred after implantation.There was also an incision enlargement to remove the lens, but no vitrectomy was performed and no sutures were used.Furthermore, the replacement lens is unknown.The patient is a female with (b)(6), and is doing very well post-operatively.In addition, the surgeon was dr.(b)(6) and the date of occurrence was (b)(6) 2017.No additional information was provided.(b)(6).Gender/sex: female.(b)(6).(b)(6).Health professional: yes.Occupation: physician.(b)(4).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: 6720369
• Report Number: 2648035-2017-01283
• Device Sequence Number: 1735963
• Product Code: HQL
• UDI-Device Identifier: 05050474548626
• UDI-Public: (01)05050474548626(17)200406
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2017

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: 04/06/2020
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 07/19/2017; 11/16/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 08/13/2017; 12/15/2017
• 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; Required Intervention
• Patient Age: 87 YR