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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: to date this lens remains implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that after implantation of a zkb00 intraocular lens (iol) the patient is seeing a horizontal line running through his vision in both eyes.The patient also has significant glare in both eyes described as horizontal glare that is not tolerable.The physician performed a yttrium-aluminum-garnet laser (yag) in the left eye; however this did not resolve the issue completely.He noted that the patient will still have the issue in the right eye, so he plans to perform a lens exchange on the right eye.The lens remains implanted and will be replaced with a non-amo monofocal device.There were no patient injury reported for this event.The physician also noted that the patient has a posterior capsule opacification (pco) on the left eye also but exchanging the lens after a yag is more challenging and risky.This report will capture the lens implanted in the patient's left eye and a separate report will be filed for the lens implanted in the patient's right eye.
Additional Manufacturer Narrative
Product testing could not be performed because the device was not returned.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer 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: 6278068
• Report Number: 9614546-2017-00050
• Device Sequence Number: 786988
• Product Code: MFK
• UDI-Device Identifier: 05050474560871
• UDI-Public: (01)05050474560871(17)200502
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2017

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: 05/02/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2017
• Supplement Report FDA Received Date: 04/19/2017
• 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