MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZKB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was inserted and removed.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was inserted into the patient's eye and it was removed, during the same surgical procedure, because it was noticed cracked.No further information was provided.
Additional Manufacturer Narrative
Corrected data/additional info: additional information was received and it was learnt that the lens with serial number (b)(4) was implanted as a replacement for the lens with serial number (b)(4).Serial #: (b)(4) and unique identifier (udi#): ((b)(4).Device available for evaluation? yes.Returned to manufacturer on: 08/04/2017.Device returned to manufacturer? yes.Reason for non-evaluation: device evaluation anticipated, but not begun.Reportedly, there was no patient injury.No incision enlargement, no vitrectomy was performed and no sutures were required.No further information was provided.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
In the supplemental mdr, it was reported that the lens was returned on 08/04/2017.In review of the file, the actual lens returned date was 08/01/2017.The file has been updated accordingly.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed that the lens was stuck in the cartridge.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 similar complaints for this order number have been 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.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.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: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6728837
• Report Number: 9614546-2017-00639
• Device Sequence Number: 16328344
• Product Code: MFK
• UDI-Device Identifier: 05050474560147
• UDI-Public: (01)05050474560147(17)200329
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/11/2017

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: 03/29/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 07/18/2017; 09/18/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 08/10/2017; 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1