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

Model Number	AAB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported a scratch on an intraocular lens (iol) during implantation into the patient's eye.Patient contact was reported.The lens was destroyed and discarded.No further information was provided.
Additional Manufacturer Narrative
Corrected data: on the initial mdr the device was reported as destroyed and discarded by the customer however the device was returned to the manufacturer.Therefore the (b)(4) that was entered on the initial mdr is no longer applicable.Additional information: through follow up the customer confirmed that the lens was in contact with the eye and then the scratch was noticed.There was no injury to the patient.A backup lens was used to complete the procedure.The replacement lens information was not provided as it was not readily available.There was no incision enlargement and no vitrectomy.The patient is ok.Device available for evaluation? yes, returned to manufacturer on 01/16/2017.Device returned to manufacturer? yes.As the device was returned to the manufacturer the (b)(4) that was entered on the initial mdr no longer applies.The returned device was evaluated and therefore (b)(4) have now been entered in evaluation codes.As a result of the additional information provided the (b)(4) that was entered on the initial mdr has now been updated to (b)(4).Device evaluation: visual inspection at 10x microscope magnification was performed.There was no indication of viscoelastics on the returned cartridge.The lens was stuck and torn at the cartridge tube.The reported device problem (scratches) could not be verified since the lens was stuck in the cartridge.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: 6236083
• Report Number: 2648035-2017-00050
• Device Sequence Number: 10828490
• Product Code: HQL
• UDI-Device Identifier: 05050474548664
• UDI-Public: (01)05050474548664(17)200504
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2017

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: 05/04/2020
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE 1MTEC30, LOT CB40892