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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017 and (b)(6) 2018.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a tecnis multifocal intraocular lens (model zkb00, +17.0 diopter) was explanted from patient''s left eye in a secondary procedure.Reportedly the lens decentered post implantation and there was unexpected post op refraction.Model zma00, +16.5 diopter intraocular lens was implanted as the replacement lens in the sulcus with no complications for the patient.No further information was provided.
Additional Manufacturer Narrative
The product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.The manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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: 7290930
• Report Number: 3011852734-2018-00022
• Device Sequence Number: 2301429
• Product Code: MFK
• UDI-Device Identifier: 05050474560024
• UDI-Public: (01)05050474560024(17)210812
• 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: 2017
• 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: 08/12/2021
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 02/22/2018
• 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