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 Codes	Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, the exact date was not provided, but the best estimate date is between (b)(6) 2017.Explant date: if explanted, give date: not applicable, as the lens remains implanted.(b)(4).Planned explant; scheduled for (b)(6) 2017.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a multifocal intraocular lens (model zkb00, +10.0 diopter) was implanted in the right eye (od) on (b)(6) 2017.However, an explant is planned for (b)(6) 2017 due to the patient seeing extreme halos when driving at night and during the day.Reportedly, the patient cannot function with these side effects.The replacement lens would be either a model ar40e or a pcb00.Additional information was provided and it was learnt that a multifocal zlb00, +7.5 diopter, was implanted in the left eye on (b)(6) 2017.The zlb00 lens will be exchanged within 1 month after the iol exchange of od.This report is to record the lens planned to be explanted from the right eye.A separate mdr is being filed for the left eye.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was discarded by the customer.The reported complaint was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: it was incorrectly reported in the initial emdr, that the date of implant was (b)(6) 2017.The correct implant date was (b)(6) 2016.This section has been updated and corrected.If implanted, give date: (b)(6) 2016.Additional information: additional information received reported the patient was a male, (b)(6), and the operative eye being the right eye.Also, an explant was performed on (b)(6) 2017 and was performed due to halos and glare.There was no incision enlargement, no vitrectomy, and no sutures used.The replacement lens was a pcb00 9.5 diopter lens.Reportedly, there was no patient injury.The lens was discarded by the customer.No additional information was provided.The additional fields were therefore updated: age/date of birth: (b)(6).Gender/sex: male.Outcomes attributed to adverse event: required intervention.If explanted, give date: (b)(6) 2017.(b)(4).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: 7047776
• Report Number: 9614546-2017-01141
• Device Sequence Number: 19128358
• Product Code: MFK
• UDI-Device Identifier: 05050474559882
• UDI-Public: (01)05050474559882(17)190323
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2018

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: 03/23/2019
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 02/15/2018; 03/21/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 03/13/2018; 04/20/2018
• 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