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

Model Number	ZKB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	02/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.If explanted; give date: n/a (not applicable).The intraocular lens remains implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
Intraocular lenses (iol) implanted in both eyes.Since then, the patient can¿t read/see print and is unable to drive due to glare.The patient is seeing rings on the iols.She said that her symptoms significantly interfere with her daily activities.The patient stated that the doctor plans to remove the left lens at a future date.Follow up with the doctor's office reported they are still reviewing and said that they are still thinking about going through explanting os (left lens) or not anymore.No additional information was provided to abbott medical optics.Note: 2 mdr¿s will be submitted, one for each eye.This report documents the events associated with the left eye.
Additional Manufacturer Narrative
The product was not returned to the manufacturing site as it remains implanted.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.The manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.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.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.
Additional Manufacturer Narrative
Additional information: additional information was received indicating that the patient could not tolerate the halo and glare from the lens; therefore, the doctor explanted the lens.It was indicated the lens was lost and will not be available for investigation.There was no patient injury reported and the patient was doing good.Based on the additional information received, the following fields have been updated: outcomes attributed to adverse event: required intervention.If explanted; give date: (b)(6) 2017.(b)(4).All pertinent information available to johnson and 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: 7026810
• Report Number: 9614546-2017-01105
• Device Sequence Number: 19185100
• Product Code: MFK
• UDI-Device Identifier: 05050474560109
• UDI-Public: (01)05050474560109(17)191203
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 12/03/2019
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 11/21/2017; 03/01/2018
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 12/15/2017; 03/30/2018
• 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: Other; Required Intervention