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

Model Number	ZKB00
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zkb00 intraocular lens (iol), 17.5 diopter was explanted from the right eye (od) of a male patient due to a decentered lens.The replacement lens was a zma00 17.0 diopter intraocular lens, implanted in the sulcus.There was no incision enlargement, no sutures required, and no vitrectomy was performed.It was reported that the patient is stable, good and no patient post-op injury was reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 4/11/2018.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturer.Visual inspection shows the product was cut in half, most probably to make explant possible.The lens was further inspected using a 12x microscope magnification and no cosmetic issue was found on returned pieces.Considering the condition of the lens additional analysis is not possible.The complaint event is not confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints history revealed no other complaints were received for this production order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.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: 7301121
• Report Number: 3011852734-2018-00024
• Device Sequence Number: 19312235
• Product Code: MFK
• UDI-Device Identifier: 05050474560031
• UDI-Public: (01)05050474560031(17)210531
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 05/31/2021
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 05/06/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 05/22/2018
• 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
• Patient Age: 80 YR