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

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a zkb00 20.5 diopter intraocular lens was explanted.Patient was post lasik and correct power was difficult to calculate.The wound was not enlarged and patient was unaffected.No further information was provided.
Additional Manufacturer Narrative
Additional information received reported there was no issue with the lens and that the doctor calculated the wrong lens power, so he removed the lens during same-day surgery (not a secondary explant).There was no incision enlargement, vitrectomy, or capsule tear.The patient is doing well.Also the physician/initial reporters name was provided, dr (b)(6).No additional information was provided.Corrected data: (b)(4).In the initial mdr initial reporter name was addressed as unknown however with the additional information provided the following fields have been updated accordingly: initial reporter: dr (b)(6).Health professional: yes.Occupation: physician.Upon further review and based on the additional information provided this complaint is no longer considered a reportable event.No further information will be provided under this manufacturer report number.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: 6768631
• Report Number: 9614546-2017-00704
• Device Sequence Number: 2064659
• Product Code: MFK
• UDI-Device Identifier: 05050474560093
• UDI-Public: (01)05050474560093(17)200422
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 08/29/2017

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: 04/22/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 08/29/2017
• 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: Required Intervention