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

Model Number	AR40E
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was inserted and then cut out from the eye in the same procedure.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
After implantation of the intraocular lens (iol), the customer noticed that the injector marked the lens.The iol had to be cut and removed from the eye.Another lens was implanted.No patient injury.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
The cartridge model and lot number were provided.Concomitant medical product: updated to reflect cartridge, model emeraldd30, lot cb31997.Device evaluation: the product was not returned for evaluation; therefore, an investigation was not possible.The customer's reported event could not be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens 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.The reported issue was not verified.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.
Additional Manufacturer Narrative
Additional information: device available for evaluation ¿ yes, returned to manufacturer on 10/26/2016.Device returned to manufacturer ¿ yes.Device evaluation: the complaint unit was received in the original folding carton.Visual inspection at 10x microscope magnification was performed.Residues of what appears to be viscoelastics are observed on the lens optic body.The lens was observed with both haptics detached.The detached haptic could be related to the handling process, since the lens has been cut and removed.Cuts on the lens were observed.The reported complaint issue was considered 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: 6012511
• Report Number: 2648035-2016-01569
• Device Sequence Number: 1397306
• Product Code: HQL
• UDI-Device Identifier: 05050474502185
• UDI-Public: (01)05050474502185(17)210303
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2016

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: 03/03/2021
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/07/2016
• Supplement Report FDA Received Date: 11/03/2016; 12/13/2016
• 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: UNKNOWN INJECTOR AND CARTRIDGE